Prescription drug · ANDA
Hydrocodone Bitartrate and Acetaminophen NDC 71335-1970
Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71335-1970Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1970Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1970-1 | 71335197001 | 30 TABLET in 1 BOTTLE (71335-1970-1)Marketed from Oct 7, 2021 | |
| 71335-1970-2 | 71335197002 | 15 TABLET in 1 BOTTLE (71335-1970-2)Marketed from Sep 6, 2024 | |
| 71335-1970-3 | 71335197003 | 28 TABLET in 1 BOTTLE (71335-1970-3)Marketed from Sep 6, 2024 | |
| 71335-1970-4 | 71335197004 | 56 TABLET in 1 BOTTLE (71335-1970-4)Marketed from Sep 6, 2024 | |
| 71335-1970-5 | 71335197005 | 60 TABLET in 1 BOTTLE (71335-1970-5)Marketed from Oct 7, 2021 | |
| 71335-1970-6 | 71335197006 | 90 TABLET in 1 BOTTLE (71335-1970-6)Marketed from Oct 26, 2021 | |
| 71335-1970-7 | 71335197007 | 120 TABLET in 1 BOTTLE (71335-1970-7)Marketed from Oct 26, 2021 |
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 — 7.5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-1970_fbff8b13-b5c4-4bfa-bd49-568fe4150ca3SPL ID fbff8b13-b5c4-4bfa-bd49-568fe4150ca3SPL set ID 080d8fbd-a2c5-45b1-a9cf-2b6dd42ec4c7RxCUI 857005UNII NO70W886KK, 362O9ITL9D
- 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
N471335197001followed by a unit qualifier and the quantityPackage 71335-1970-01. 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 | NuCare Pharmaceuticals,Inc. | 68071-3447 |
| 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 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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