Prescription drug · ANDA
Hydrocodone Bitartrate and Acetaminophen NDC 76420-876
Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-876-00 | 76420087600 | 1000 TABLET in 1 BOTTLE, PLASTIC (76420-876-00)Marketed from Nov 12, 2024 | |
| 76420-876-01 | 76420087601 | 1 TABLET in 1 BOTTLE, PLASTIC (76420-876-01)Marketed from Nov 12, 2024 | |
| 76420-876-03 | 76420087603 | 3 TABLET in 1 BOTTLE, PLASTIC (76420-876-03)Marketed from Nov 12, 2024 | |
| 76420-876-05 | 76420087605 | 500 TABLET in 1 BOTTLE, PLASTIC (76420-876-05)Marketed from Nov 12, 2024 | |
| 76420-876-07 | 76420087607 | 7 TABLET in 1 BOTTLE, PLASTIC (76420-876-07)Marketed from Nov 12, 2024 | |
| 76420-876-10 | 76420087610 | 100 TABLET in 1 BOTTLE, PLASTIC (76420-876-10)Marketed from Nov 12, 2024 | |
| 76420-876-14 | 76420087614 | 14 TABLET in 1 BOTTLE, PLASTIC (76420-876-14)Marketed from Nov 12, 2024 | |
| 76420-876-20 | 76420087620 | 20 TABLET in 1 BOTTLE, PLASTIC (76420-876-20)Marketed from Nov 12, 2024 | |
| 76420-876-30 | 76420087630 | 30 TABLET in 1 BOTTLE, PLASTIC (76420-876-30)Marketed from Nov 12, 2024 | |
| 76420-876-60 | 76420087660 | 60 TABLET in 1 BOTTLE, PLASTIC (76420-876-60)Marketed from Nov 12, 2024 | |
| 76420-876-90 | 76420087690 | 90 TABLET in 1 BOTTLE, PLASTIC (76420-876-90)Marketed from Nov 12, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Asclemed USA, Inc.
- 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 76420-876_338382b0-08f4-67b8-e063-6294a90a0da4SPL ID 338382b0-08f4-67b8-e063-6294a90a0da4SPL set ID ba7d27eb-952d-4e99-95b9-5b0b2f85794bRxCUI 856999, 857002, 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
N476420087600followed by a unit qualifier and the quantityPackage 76420-0876-00. 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, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ] , reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone Bitartrate and Acetaminophen Tablets s…
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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