Prescription drug · ANDA
Hydrocodone Bitartrate and Acetaminophen NDC 71335-9734
Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9734-0 | 71335973400 | 10 TABLET in 1 BOTTLE, PLASTIC (71335-9734-0)Marketed from Jun 8, 2023 | |
| 71335-9734-1 | 71335973401 | 30 TABLET in 1 BOTTLE, PLASTIC (71335-9734-1)Marketed from May 15, 2023 | |
| 71335-9734-2 | 71335973402 | 120 TABLET in 1 BOTTLE, PLASTIC (71335-9734-2)Marketed from May 30, 2023 | |
| 71335-9734-3 | 71335973403 | 20 TABLET in 1 BOTTLE, PLASTIC (71335-9734-3)Marketed from May 30, 2023 | |
| 71335-9734-4 | 71335973404 | 60 TABLET in 1 BOTTLE, PLASTIC (71335-9734-4)Marketed from Jun 2, 2023 | |
| 71335-9734-5 | 71335973405 | 90 TABLET in 1 BOTTLE, PLASTIC (71335-9734-5)Marketed from Oct 18, 2023 | |
| 71335-9734-6 | 71335973406 | 50 TABLET in 1 BOTTLE, PLASTIC (71335-9734-6)Marketed from Apr 9, 2026 | |
| 71335-9734-7 | 71335973407 | 40 TABLET in 1 BOTTLE, PLASTIC (71335-9734-7)Marketed from Oct 17, 2023 | |
| 71335-9734-8 | 71335973408 | 15 TABLET in 1 BOTTLE, PLASTIC (71335-9734-8)Marketed from May 30, 2023 | |
| 71335-9734-9 | 71335973409 | 84 TABLET in 1 BOTTLE, PLASTIC (71335-9734-9)Marketed from Apr 9, 2026 |
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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202214
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 71335-9734_368725ec-f1df-4f17-a2e0-3bd5d4cb89d8SPL ID 368725ec-f1df-4f17-a2e0-3bd5d4cb89d8SPL set ID 8e99994a-83b4-4b1f-9654-4ae373bf2c4dRxCUI 857002UNII 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
N471335973400followed by a unit qualifier and the quantityPackage 71335-9734-00. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ] , reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202214
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 Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-692 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2294 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2292 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2293 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2298 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2295 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2296 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2297 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2299 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2300 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2308 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2309 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2310 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3685 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2969 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2740 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-873 |
| Hydrocodone Bitartrate and Acetaminophen | Acetaminophen 325 mg/1; Hydrocodone bitartrate 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-872 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2238 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-036 |
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