Prescription drug · ANDA
Hydrocodone Bitartrate NDC 47781-413
Hydrocodone bitartrate 40 mg/1 · Capsule, Extended release · Oral · Alvogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-413-60 | 47781041360 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-413-60)Marketed from Jan 21, 2020 |
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
- Generic name (nonproprietary)
- hydrocodone bitartrate
- Active ingredients
- Hydrocodone bitartrate — 40 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Alvogen Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206986
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 47781-413_efb4a6cd-a407-a935-70b9-6ab1074ca819SPL ID efb4a6cd-a407-a935-70b9-6ab1074ca819SPL set ID a7b8ea07-e926-f0a5-c20d-92f23ed350d0RxCUI 1860491, 1860493, 1860495, 1860497, 1860499, 1860501UNII NO70W886KKUPC 0347781412609, 0347781411602, 0347781410605, 0347781413606, 0347781409609, 0347781414603
- 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
N447781041360followed by a unit qualifier and the quantityPackage 47781-0413-60. 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)
Hydrocodone bitartrate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, [see Warnings and Precautions (5.1)] , reserve hydrocodone bitartrate extended-release capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206986
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 | Hydrocodone bitartrate 30 mg/1 | Capsule, Extended releaseOral | Alvogen Inc. | 47781-412 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 10 mg/1 | Capsule, Extended releaseOral | Alvogen Inc. | 47781-409 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 15 mg/1 | Capsule, Extended releaseOral | Alvogen Inc. | 47781-410 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 20 mg/1 | Capsule, Extended releaseOral | Alvogen Inc. | 47781-411 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 50 mg/1 | Capsule, Extended releaseOral | Alvogen Inc. | 47781-414 |