Prescription drug · ANDA
Alendronate Sodium NDC 0115-1681
Alendronate sodium 70 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1681-26 | 00115168126 | 12 BLISTER PACK in 1 CARTON (0115-1681-26) / 1 TABLET in 1 BLISTER PACK (0115-1681-30)Marketed from Feb 6, 2008 | |
| 0115-1681-34 | 00115168134 | 4 BLISTER PACK in 1 CARTON (0115-1681-34) / 1 TABLET in 1 BLISTER PACK (0115-1681-30)Marketed from Feb 6, 2008 |
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)
- Alendronate Sodium
- Generic name (nonproprietary)
- alendronate sodium
- Active ingredients
- Alendronate sodium — 70 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075710
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 0115-1681_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1SPL ID 0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1SPL set ID c23fb7fe-c6b9-4f77-bde7-992222b589d3RxCUI 904396, 904405, 904419, 904425, 904431UNII 2UY4M2U3RAUPC 0301151681347, 0301151679344, 0301151676084, 0301151678088, 0301151680081
- Pharmacologic class
- Bisphosphonate
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
N400115168126followed by a unit qualifier and the quantityPackage 00115-1681-26. 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)
Alendronate sodium tablets are a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1 , 1.2 ) Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Treatment of glucocorticoid-induced osteoporosis ( 1.4 ) Treatment of Paget's disease of bone ( 1.5 ) Limitations of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.6 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets increase bon…
Excerpt only. Read the full label for complete information.
About NDC 0115-1681
- What is NDC 0115-1681?
- 0115-1681 is the product NDC for Alendronate Sodium, Alendronate sodium 70 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alendronate Sodium.
- What is the active ingredient?
- Alendronate sodium.
- Who is the labeler?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alendronate Sodium?
- 27 other product NDCs are listed under this name. See all Alendronate Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alendronate Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alendronate Sodium | Alendronate sodium 70 mg/75mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-264 | 70954-0264-10 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-681 | 76282-0681-46 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-682 | 76282-0682-46 |
| Alendronate Sodium | Alendronate sodium 70 mg/75mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-0282 | 00054-0282-59 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1192 | 70518-1192-01 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7130 | 68788-7130-04 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0033 | 70518-0033-00 |
| Alendronate Sodium | Alendronate sodium 10 mg/1 | TabletOral | NorthStar Rx LLC | 16714-631 | 16714-0631-0116714-0631-0216714-0631-11 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | NorthStar Rx LLC | 16714-632 | 16714-0632-0116714-0632-0216714-0632-11 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | NorthStar Rx LLC | 16714-633 | 16714-0633-0116714-0633-0216714-0633-11 |
Other NDCs under ANDA 075710
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 |
|---|---|---|---|---|
| Alendronate Sodium | Alendronate sodium 5 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1676 |
| Alendronate Sodium | Alendronate sodium 10 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1678 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1679 |
| Alendronate Sodium | Alendronate sodium 40 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1680 |