HYDROCODONE/APAP
- Product NDC
- 54348-066
- 11-digit product format
- 543480066
- Labeler code
- 54348
- Product ID
- 54348-066_d0bab4bf-d2a1-4a7a-9141-3b9a7ffc9975
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE, ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- ANDA040736
- Marketing category
- ANDA
- Marketing start
- 2014-09-01
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 54348-066-01 | HYDROCODONE/APAP | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
| 54348-066-01 | HYDROCODONE/APAP | 1 in 1 BOX | TABLET | 1 | | 2 |
| 54348-066-10 | HYDROCODONE/APAP | 10 in 1 BOTTLE | TABLET | 10 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54348-066 | HYDROCODONE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [PHARMPAK, INC.] | 2 | Legacy NDC, 3 package rows | 20150115_fcff467e-ddcb-48d1-ac8b-a8e4435eebb2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 54348-066-01 | 54348006601 | 1 in 1 BLISTER PACK | Historical |
| 54348-066-10 | 54348006610 | 10 in 1 BOTTLE | Historical |