Prescription drug · ANDA
hydrocodone bitartrate and acetaminophen NDC 63629-1183
Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1183-1 | 63629118301 | 100 TABLET in 1 BOTTLE (63629-1183-1)Marketed from Nov 9, 2022 |
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 — 10 mg/1Acetaminophen — 300 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 207509
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 63629-1183_f8c55dd3-a7a6-4c34-a799-828c9ebadb91SPL ID f8c55dd3-a7a6-4c34-a799-828c9ebadb91SPL set ID 1cdeaf5e-5f82-4820-b244-b0ec7a7307e1RxCUI 856980UNII 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
N463629118301followed by a unit qualifier and the quantityPackage 63629-1183-01. 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
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 an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [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
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207509
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 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1177 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1179 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1184 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1180 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1181 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1996 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1997 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1998 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Eywa Pharma Inc | 71930-042 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Eywa Pharma Inc | 71930-043 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 | TabletOral | Eywa Pharma Inc | 71930-044 |