Prescription drug · ANDA
Hydrocodone Bitartrate and Acetaminophen NDC 68071-3447
Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3447-3 | 68071344703 | 30 TABLET in 1 BOTTLE (68071-3447-3)Marketed from Jun 23, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Hydrocodone Bitartrate and Acetaminophen
- Generic name (nonproprietary)
- hydrocodone bitartrate and acetaminophen
- Active ingredients
- Hydrocodone bitartrate — 5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210211
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68071-3447_2d67b889-65d1-1c00-e063-6394a90a3d24SPL ID 2d67b889-65d1-1c00-e063-6394a90a3d24SPL set ID fed1eb12-3e39-1bf9-e053-6294a90afd77RxCUI 857002UNII NO70W886KK, 362O9ITL9DUPC 0368071344738
- Pharmacologic class
- Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468071344703followed by a unit qualifier and the quantityPackage 68071-3447-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 210211
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hydrocodone/APAP | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Direct_Rx | 72189-649 |
| Hydrocodone/APAP | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Direct_Rx | 72189-650 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2116 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8885 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8886 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2144 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Redpharm Drug | 67296-2201 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1989 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1990 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1991 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 87063-051 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 87063-049 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 87063-050 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1939 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1938 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1940 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2494 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1970 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | American Health Packaging | 60687-396 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | American Health Packaging | 60687-407 |
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