Prescription drug · ANDA
Alendronate Sodium NDC 68788-7130
Alendronate sodium 70 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7130-4 | 68788713004 | 4 TABLET in 1 BLISTER PACK (68788-7130-4)Marketed from Mar 30, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076768
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 68788-7130_e88fb31d-cfc6-4e20-95fa-90fa26bf8644SPL ID e88fb31d-cfc6-4e20-95fa-90fa26bf8644SPL set ID 83e3ba94-d882-4b5c-87cb-af1eb0997efcRxCUI 904431UNII 2UY4M2U3RA
- 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
N468788713004followed by a unit qualifier and the quantityPackage 68788-7130-04. 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)
Alendronate sodium is 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, USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets, USP in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076768
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 35 mg/1 | TabletOral | Cipla USA Inc. | 69097-223 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | Cipla USA Inc. | 69097-224 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | A-S Medication Solutions | 50090-4692 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3340 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1192 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-681 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-682 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3771 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0033 |