Prescription drug · ANDA
Albendazole NDC 46708-681
Albendazole 200 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-681-02 | 46708068102 | 2 TABLET, FILM COATED in 1 BOTTLE (46708-681-02)Marketed from Sep 11, 2024 | |
| 46708-681-28 | 46708068128 | 28 TABLET, FILM COATED in 1 BOTTLE (46708-681-28)Marketed from Sep 11, 2024 |
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)
- Albendazole
- Generic name (nonproprietary)
- albendazole
- Active ingredients
- Albendazole — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215652
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A Inducers (Mechanism)
- Identifiers
- Product ID 46708-681_3b4945c7-56e9-47ed-a7ac-5078a1a50b85SPL ID 3b4945c7-56e9-47ed-a7ac-5078a1a50b85SPL set ID 3b4945c7-56e9-47ed-a7ac-5078a1a50b85RxCUI 199672UNII F4216019LN
- Pharmacologic class
- Anthelmintic
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
N446708068102followed by a unit qualifier and the quantityPackage 46708-0681-02. 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)
Albendazole tablets are an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . (1.1) Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus .(1.2) 1.1 Neurocysticercosis Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . 1.2 Hydatid Disease Albendazole tablets are indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of th…
Excerpt only. Read the full label for complete information.
About NDC 46708-681
- What is NDC 46708-681?
- 46708-681 is the product NDC for Albendazole, Albendazole 200 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Albendazole.
- What is the active ingredient?
- Albendazole.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Albendazole?
- 8 other product NDCs are listed under this name. See all Albendazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Albendazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Albendazole | Albendazole 200 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-681 | 62332-0681-0262332-0681-28 |
| Albendazole | Albendazole 200 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-051 | 72205-0051-0872205-0051-28 |
| Albendazole | Albendazole 200 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2359 | 72162-2359-02 |
| Albendazole | Albendazole 200 mg/1 | Tablet, Film coatedOral | Dr.Reddys Laboratories Inc | 43598-452 | 43598-0452-0243598-0452-1743598-0452-63 |
| Albendazole | Albendazole 200 mg/1 | Tablet, Film coatedOral | Actavis Pharma, Inc. | 0591-2712 | 00591-2712-02 |
| Albendazole | Albendazole 200 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-110 | 42799-0110-02 |
| Albendazole | Albendazole 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-258 | 51407-0258-02 |
| Albendazole | Albendazole 200 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 0115-1701 | 00115-1701-49 |
Other NDCs under ANDA 215652
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 |
|---|---|---|---|---|
| Albendazole | Albendazole 200 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-681 |