HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 57664-170
- 11-digit product format
- 576640170
- Labeler code
- 57664
- Product ID
- 57664-170_e4d8d15c-2a44-443d-8b50-e41095925da1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090118
- Marketing category
- ANDA
- Marketing start
- 2009-03-30
- Marketing end
- 2021-08-31
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57664-170-08 | 57664017008 | 100 TABLET in 1 BOTTLE (57664-170-08) | 100 tablet | 2009-03-30 | 2021-08-31 | No | No | Current |
| 57664-170-18 | 57664017018 | 1000 TABLET in 1 BOTTLE (57664-170-18) | 1000 tablet | 2009-03-30 | 2021-08-31 | No | No | Current |
| 57664-170-83 | 57664017083 | 30 TABLET in 1 BOTTLE (57664-170-83) | 30 tablet | 2009-03-30 | 2021-08-31 | No | No | Current |
| 57664-170-88 | 57664017088 | 100 TABLET in 1 BOTTLE (57664-170-88) | 100 tablet | 2009-03-30 | 2021-08-31 | No | No | Current |