Home NDC 42254-300 Hydrocodone Bitartate and Acetaminophen
Product NDC 42254-300
11-digit product format 422540300
Labeler code 42254
Product ID 42254-300_a05c255c-6e0b-4e86-b907-738b777fc524
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCODONE BITARTRATE, ACETAMINOPHEN
Dosage form TABLET
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA040846
Marketing category ANDA
Marketing start 2012-05-17
Marketing end 0000-00-00
Substance HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength 3 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule CIII
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42254-300-30 Hydrocodone Bitartate and Acetaminophen 30 in 1 BOTTLE, PLASTIC TABLET 30 1 42254-300-60 Hydrocodone Bitartate and Acetaminophen 60 in 1 BOTTLE, PLASTIC TABLET 60 1 42254-300-90 Hydrocodone Bitartate and Acetaminophen 90 in 1 BOTTLE, PLASTIC TABLET 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 HYDROCODONE BITARTRATE ACTIVE INGREDIENT NO70W886KK HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42254-300 HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 3 package rows 20121129_a05c255c-6e0b-4e86-b907-738b777fc524.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42254-300-30 42254030030 30 in 1 BOTTLE, PLASTIC Historical 42254-300-60 42254030060 60 in 1 BOTTLE, PLASTIC Historical 42254-300-90 42254030090 90 in 1 BOTTLE, PLASTIC Historical