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US Food and Drug Administration (FDA) - Inactive Ingredients

FDA Inactive Ingredients - Updated May 2006

What is the purpose of the Inactive Ingredients Database?

The Inactive Ingredients Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. For new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product.
FDA Devices
FDA Inactive Ingredients
FDA Inactive Ingredients
FDA Inactive Ingredients


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Inactive Ingredient Route / Dosage Form
OPACODE A-10450 BLACK ORAL; CAPSULE
OPACODE A-10450 BLACK ORAL; TABLET
OPACODE A-10450 BLACK ORAL; TABLET, FILM COATED
OPACODE A-10509 BLACK ORAL; CAPSULE
OPACODE NS-78-10013-N ORAL; TABLET
OPACODE NS-78-17502 GRAY ORAL; TABLET, FILM COATED
OPACODE NS-78-8000 BLACK ORAL; TABLET
OPACODE NS-78-8000 BLACK ORAL; TABLET, COATED
OPACODE NS-78-8000 BLACK ORAL; TABLET, FILM COATED
OPACODE NS-78-8000 BLACK ORAL; TABLET, SUSTAINED ACTION
OPACODE NS-78-8001 ORAL; CAPSULE, SOFT GELATIN
OPACODE NS-78-8001 ORAL; TABLET, EXTENDED RELEASE
OPACODE NS-78-8001 ORAL; TABLET, SUSTAINED ACTION
OPACODE NS-78-8001 ORAL; TABLET, SUSTAINED ACTION, FILM COATED
OPACODE NSP-78-17734 BLACK ORAL; CAPSULE, SOFT GELATIN
OPACODE S-1-13001 ORANGE ORAL; TABLET
OPACODE S-1-15034-FD RED ORAL; TABLET, FILM COATED
OPACODE S-1-15038 RED ORAL; TABLET
OPACODE S-1-16507 ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
OPACODE S-1-1666 RED ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
OPACODE S-1-1666 RED ORAL; TABLET, FILM COATED
OPACODE S-1-1666 RED ORAL; TABLET, SUSTAINED ACTION, COATED
OPACODE S-1-1666-M RED ORAL; TABLET, FILM COATED
OPACODE S-1-1681 RED ORAL; CAPSULE
OPACODE S-1-17706 BLACK ORAL; TABLET, SUSTAINED ACTION
OPACODE S-1-17711 BLACK ORAL-21; TABLET, COATED
OPACODE S-1-17711 BLACK ORAL-28; TABLET, COATED
OPACODE S-1-17734 BLACK ORAL; TABLET
OPACODE S-1-17734 BLACK ORAL; TABLET, FILM COATED
OPACODE S-1-17749 BLACK ORAL; CAPSULE, EXTENDED RELEASE
OPACODE S-1-17749 BLACK ORAL; CAPSULE, SUSTAINED ACTION
OPACODE S-1-17797 BLACK ORAL; TABLET
OPACODE S-1-18025 WHITE ORAL; TABLET, FILM COATED
OPACODE S-1-26514 BROWN ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
OPACODE S-1-3110 GREEN ORAL; TABLET
OPACODE S-1-3171 GREEN ORAL; TABLET, SUSTAINED ACTION
OPACODE S-1-4124 BLUE ORAL; TABLET, SUSTAINED ACTION
OPACODE S-1-4157 ORAL; CAPSULE, SOFT GELATIN
OPACODE S-1-4159 BLACK ORAL; TABLET, EXTENDED RELEASE
OPACODE S-1-4160 BLUE ORAL; TABLET
OPACODE S-1-4160 BLUE ORAL; TABLET, SUSTAINED ACTION
OPACODE S-1-4160 BLUE ORAL; TABLET, SUSTAINED RELEASE, FILM COATED
OPACODE S-1-4172 BLUE ORAL; TABLET, FILM COATED
OPACODE S-1-4172M BLUE ORAL; TABLET, FILM COATED
OPACODE S-1-4362 ORAL; TABLET, SUSTAINED ACTION
OPACODE S-1-7020 ORAL; CAPSULE
OPACODE S-1-7077 ORAL; CAPSULE
OPACODE S-1-7078 ORAL; CAPSULE
OPACODE S-1-7085 WHITE ORAL; CAPSULE
OPACODE S-1-7085 WHITE ORAL; CAPSULE, SUSTAINED ACTION
OPACODE S-1-7090 WHITE ORAL; TABLET, FILM COATED
OPACODE S-1-7534 GRAY ORAL; TABLET
OPACODE S-1-800HV BLACK ORAL; CAPSULE
OPACODE S-1-800HV BLACK ORAL; TABLET, CONTROLLED RELEASE
OPACODE S-1-8025 BLACK ORAL; CAPSULE
OPACODE S-1-8025 BLACK ORAL; TABLET
OPACODE S-1-8081 BLACK ORAL; TABLET
OPACODE S-1-8090 BLACK ORAL; CAPSULE
OPACODE S-1-8090 BLACK ORAL; CAPSULE, SOFT GELATIN
OPACODE S-1-8090 BLACK ORAL; TABLET
OPACODE S-1-8090 BLACK ORAL; TABLET, COATED
OPACODE S-1-8090 BLACK ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
OPACODE S-1-8090 BLACK ORAL; TABLET, EXTENDED RELEASE
OPACODE S-1-8090 BLACK ORAL; TABLET, FILM COATED
OPACODE S-1-8090 BLACK ORAL; TABLET, SUSTAINED ACTION, FILM COATED
OPACODE S-1-8092 BLACK ORAL; CAPSULE
OPACODE S-1-8093 BLACK ORAL; TABLET
OPACODE S-1-8093 BLACK ORAL; TABLET, FILM COATED
OPACODE S-1-8095 ORAL; TABLET, FILM COATED
OPACODE S-1-8100-HV BLACK ORAL; CAPSULE
OPACODE S-1-8100-HV BLACK ORAL; TABLET
OPACODE S-1-8100-HV BLACK ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
OPACODE S-1-8100-HV BLACK ORAL; TABLET, SUGAR COATED
OPACODE S-1-8100-HV BLACK ORAL; TABLET, SUSTAINED ACTION
OPACODE S-1-8105 BLACK ORAL; TABLET
OPACODE S-1-8105 BLACK ORAL; TABLET, FILM COATED
OPACODE S-1-8105 BLACK ORAL; TABLET, SUSTAINED ACTION
OPACODE S-1-8106 BLACK ORAL; TABLET
OPACODE S-1-8106 BLACK ORAL; TABLET, SUSTAINED ACTION
OPACODE S-1-8106 BLACK ORAL; TABLET, SUSTAINED ACTION, COATED
OPACODE S-1-8109 BLACK ORAL; TABLET, SUSTAINED ACTION, COATED
OPACODE S-1-8110 BLACK ORAL; CAPSULE
OPACODE S-1-8114 BLACK ORAL; CAPSULE
OPACODE S-1-8114 BLACK ORAL; CAPSULE, HARD GELATIN
OPACODE S-1-8114 BLACK ORAL; CAPSULE, SUSTAINED ACTION
OPACODE S-1-8115 BLACK ORAL; CAPSULE
OPACODE S-1-8115 BLACK ORAL; CAPSULE, HARD GELATIN
OPACODE S-1-8115 BLACK ORAL; CAPSULE, SUSTAINED ACTION
OPACODE S-1-8152HV BLACK ORAL; CAPSULE
OPACODE S-1-8152HV BLACK ORAL; TABLET
OPACODE S-1-9009 BROWN ORAL; TABLET, COATED
OPACODE S-1-9032 ORAL; TABLET
OPACODE S-1-9037 BROWN ORAL; TABLET, SUSTAINED ACTION
OPACODE S-1-9048C ORAL; TABLET, SUSTAINED ACTION
OPACODE S-1-9460HV BROWN ORAL; CAPSULE
OPACODE S-19-7014 WHITE ORAL; CAPSULE, SUSTAINED ACTION
OPACODE S-8-20931 ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
OPACODE SB-4028 GREEN ORAL; CAPSULE
OPACODE WB NS-78-10521 BLUE ORAL; TABLET
OPACODE WB NS-78-17715 BLACK ORAL; TABLET

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Last Modified: 29 April 2006
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