Prescription drug · ANDA
Hydrocodone Bitartrate NDC 47781-392
Hydrocodone bitartrate 20 mg/1 · Tablet, Extended release · Oral · Alvogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-392-60 | 47781039260 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-392-60)Marketed from Mar 3, 2021 |
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 — 20 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Alvogen Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208269
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 47781-392_c0f6333c-1d3f-3519-b157-cf817bd5c81dSPL ID c0f6333c-1d3f-3519-b157-cf817bd5c81dSPL set ID f7b55d14-0980-b680-8ceb-7489ff65455eRxCUI 1595730, 1595740, 1595746, 1595752, 1595758, 1595764, 1595770UNII NO70W886KKUPC 0347781394608, 0347781397609, 0347781395605, 0347781398606, 0347781392604, 0347781396602, 0347781393601
- 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
N447781039260followed by a unit qualifier and the quantityPackage 47781-0392-60. 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 tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 and Precautions ( 5.1 )] , reserve opioid analgesics, including hydrocodone bitartrate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208269
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 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-393 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 40 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-394 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 60 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-395 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 80 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-396 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 100 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-397 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 120 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-398 |