Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 17856-0640
- 11-digit product format
- 178560640
- Labeler code
- 17856
- Product ID
- 17856-0640_1ac3e745-9f9b-0f7d-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate, Acetaminophen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corps
- Application
- ANDA040894
- Marketing category
- ANDA
- Marketing start
- 2011-07-27
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325 mg/15mL; mg/15mL
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 17856-0640-2 | Hydrocodone Bitartrate and Acetaminophen | 15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 15 | | 4 |
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, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| ETHYL MALTOL | INACTIVE INGREDIENT | L6Q8K29L05 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-0640 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 4 | Legacy NDC, 1 package rows | 20150713_21539e8e-a9b9-49ab-9134-c2cdc0a54321.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 17856-0640-2 | 17856064002 | 15 mL in 1 CUP, UNIT-DOSE | 15 ml | Historical |