Prescription drug · ANDA
Acamprosate Calcium NDC 0904-7213
Acamprosate calcium 333 mg/1 · Tablet, Delayed release · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7213-04 | 00904721304 | 30 BLISTER PACK in 1 CARTON (0904-7213-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jul 16, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Acamprosate Calcium
- Generic name (nonproprietary)
- acamprosate calcium
- Active ingredients
- Acamprosate calcium — 333 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202229
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-7213_70a2162f-c686-46f6-9fe2-6c2e4f36fc21SPL ID 70a2162f-c686-46f6-9fe2-6c2e4f36fc21SPL set ID ae6e79c0-a307-4888-b647-1b7be4cb9127RxCUI 835726UNII 59375N1D0U
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
N400904721304followed by a unit qualifier and the quantityPackage 00904-7213-04. 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 .
Indications (excerpt from the label)
Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202229
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 |
|---|---|---|---|---|
| Acamprosate Calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-435 |
| Acamprosate Calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-121 |