Zamicet

Product NDC
0486-0771
11-digit product format
004860771
Labeler code
0486
Product ID
0486-0771_0a8d376c-6ccd-4f17-a291-46d367d8db83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA040834
Marketing category
ANDA
Marketing start
2015-03-18
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10 mg/15mL; mg/15mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0486-0771-16ML - Milliliter0486-0771e156a1b8-05da-49ed-aa55-83067f0db0ef12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7ZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554ZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0486-0771ZAMICET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1Legacy NDC20150407_43c30b52-7bfb-4d0f-abcf-465c919a10bf.zip