Prescription drug · ANDA
Alendronate Sodium NDC 70954-264
Alendronate sodium 70 mg/75mL · Solution · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-264-10 | 70954026410 | 4 BOTTLE in 1 CARTON (70954-264-10) / 75 mL in 1 BOTTLEMarketed from May 24, 2023 |
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)
- Alendronate Sodium
- Generic name (nonproprietary)
- alendronate sodium
- Active ingredients
- Alendronate sodium — 70 mg/75mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214512
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 70954-264_844cce5a-3714-4394-be02-a25a6255330aSPL ID 844cce5a-3714-4394-be02-a25a6255330aSPL set ID 81589178-10c9-4806-91eb-54e638d35b8dRxCUI 904447UNII 2UY4M2U3RAUPC 0370954264101
- 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
N470954026410followed by a unit qualifier and the quantityPackage 70954-0264-10. 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 Oral Solution is a bisphosphonate indicated for: Treatment of osteoporosis in postmenopausal women (1.1) Treatment to increase bone mass in men with osteoporosis (1.3) 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 is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures) [ see Clinical Studies (14.1)…
Excerpt only. Read the full label for complete information.