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 | 4778104136047781041360 | 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.NDC labeler code 47781
- 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_3bdd85f7-51e5-bd1a-ad5c-f23a7bf0ea7cSPL ID 3bdd85f7-51e5-bd1a-ad5c-f23a7bf0ea7c
- 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 47781-413
- What is NDC 47781-413?
- 47781-413 is the product NDC for Hydrocodone Bitartrate, Hydrocodone bitartrate 40 mg/1 capsule, extended release, listed with the FDA by Alvogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocodone Bitartrate.
- What is the active ingredient?
- Hydrocodone bitartrate.
- Who is the labeler?
- Alvogen Inc., NDC labeler code 47781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrocodone Bitartrate?
- 12 other product NDCs are listed under this name. See all Hydrocodone Bitartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocodone Bitartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrocodone Bitartrate | Hydrocodone bitartrate 20 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-392 | 47781-0392-60 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 30 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-393 | 47781-0393-60 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 40 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-394 | 47781-0394-60 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 60 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-395 | 47781-0395-60 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 80 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-396 | 47781-0396-60 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 100 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-397 | 47781-0397-60 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 120 mg/1 | Tablet, Extended releaseOral | Alvogen Inc. | 47781-398 | 47781-0398-60 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 10 mg/1 | Capsule, Extended releaseOral | Alvogen Inc. | 47781-409 | 47781-0409-60 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 15 mg/1 | Capsule, Extended releaseOral | Alvogen Inc. | 47781-410 | 47781-0410-60 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 20 mg/1 | Capsule, Extended releaseOral | Alvogen Inc. | 47781-411 | 47781-0411-60 |
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 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 30 mg/1 | Capsule, Extended releaseOral | Alvogen Inc. | 47781-412 |
| Hydrocodone Bitartrate | Hydrocodone bitartrate 50 mg/1 | Capsule, Extended releaseOral | Alvogen Inc. | 47781-414 |