FDA.reportPublic FDA data

Roxicet

Product NDC
0054-4650
11-digit product format
000544650
Labeler code
0054
Product ID
0054-4650_287496b8-2d45-4949-8194-d540281c2532
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp
Application
ANDA087003
Marketing category
ANDA
Marketing start
1991-02-01
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0054-4650-252025-09-04C16284748780-19d75b9d1-1d07-f424-e053-dadaa90a57ce86817b05-450c-4af0-aeea-acba2ac00601
0054-4650-292025-09-04C16284748780-19d75b9d1-1d07-f424-e053-dadaa90a57ce86817b05-450c-4af0-aeea-acba2ac00601
0054-4650-252020-01-31C16284748780-19d75b9d1-1d07-f424-e053-dadaa90a57ce86817b05-450c-4af0-aeea-acba2ac00601
0054-4650-292020-01-31C16284748780-19d75b9d1-1d07-f424-e053-dadaa90a57ce86817b05-450c-4af0-aeea-acba2ac00601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-4650-25EA - Each0054-4650b5a2336b-c3e7-4ac8-9d9b-0d05d9c7367d12012-07-24
0054-4650-29EA - Each0054-46508ce7026c-dee0-450a-a337-f8def6c1e9da12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6CROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
ACETAMINOPHENACTIVE MOIETY362O9ITL9DROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
OXYCODONEACTIVE MOIETYCD35PMG570ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
ALCOHOLINACTIVE INGREDIENT3K9958V90MROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-4650ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [WEST-WARD PHARMACEUTICALS CORP]14Legacy NDC20160812_86817b05-450c-4af0-aeea-acba2ac00601.zip