HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 42549-557
- 11-digit product format
- 425490557
- Labeler code
- 42549
- Product ID
- 42549-557_fe5ba386-ea2e-4884-9ce7-f00f71d4c101
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- STAT Rx USA LLC
- Application
- ANDA040405
- Marketing category
- ANDA
- Marketing start
- 2010-04-22
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 8 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 |
|---|
| 42549-557-02 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 112 in 1 BOTTLE | TABLET | 112 | | 5 |
| 42549-557-04 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 140 in 1 BOTTLE | TABLET | 140 | | 5 |
| 42549-557-12 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 120 in 1 BOTTLE | TABLET | 120 | | 5 |
| 42549-557-28 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 28 in 1 BOTTLE | TABLET | 28 | | 5 |
| 42549-557-30 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 42549-557-40 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 40 in 1 BOTTLE | TABLET | 40 | | 5 |
| 42549-557-56 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 56 in 1 BOTTLE | TABLET | 56 | | 5 |
| 42549-557-60 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 42549-557-84 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 84 in 1 BOTTLE | TABLET | 84 | | 5 |
| 42549-557-90 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42549-557 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC] | 5 | Legacy NDC, 10 package rows | 20120202_c8be6c8d-7c55-459b-bc16-7651c2fd6e27.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 42549-557-02 | 42549055702 | 112 in 1 BOTTLE | Historical |
| 42549-557-04 | 42549055704 | 140 in 1 BOTTLE | Historical |
| 42549-557-12 | 42549055712 | 120 in 1 BOTTLE | Historical |
| 42549-557-28 | 42549055728 | 28 in 1 BOTTLE | Historical |
| 42549-557-30 | 42549055730 | 30 in 1 BOTTLE | Historical |
| 42549-557-40 | 42549055740 | 40 in 1 BOTTLE | Historical |
| 42549-557-56 | 42549055756 | 56 in 1 BOTTLE | Historical |
| 42549-557-60 | 42549055760 | 60 in 1 BOTTLE | Historical |
| 42549-557-84 | 42549055784 | 84 in 1 BOTTLE | Historical |
| 42549-557-90 | 42549055790 | 90 in 1 BOTTLE | Historical |