Prescription drug · ANDA
Alendronate Sodium NDC 16714-631
Alendronate sodium 10 mg/1 · Tablet · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-631-01 | 16714063101 | 30 TABLET in 1 BOTTLE (16714-631-01)Marketed from Aug 4, 2008 | |
| 16714-631-02 | 16714063102 | 100 TABLET in 1 BOTTLE (16714-631-02)Marketed from Aug 4, 2008 | |
| 16714-631-11 | 16714063111 | 10 BLISTER PACK in 1 CARTON (16714-631-11) / 10 TABLET in 1 BLISTER PACK (16714-631-10)Marketed from Aug 4, 2008 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090124
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 16714-631_aed28579-c63c-48b1-8b67-e24137d0709aSPL ID aed28579-c63c-48b1-8b67-e24137d0709aSPL set ID 4323d3aa-cbb0-41e2-aba7-7a94a0516993RxCUI 904396, 904419, 904431UNII 2UY4M2U3RAUPC 0316714631011, 0316714631110
- 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
N416714063101followed by a unit qualifier and the quantityPackage 16714-0631-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 090124
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 70 mg/1 | TabletOral | A-S Medication Solutions | 50090-3126 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | Proficient Rx LP | 71205-048 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-328 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | A-S Medication Solutions | 50090-5474 |
| Alendronate Sodium | Alendronate sodium 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-327 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-329 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | A-S Medication Solutions | 50090-5677 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-342 |
| Alendronate Sodium | Alendronate sodium 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-340 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-341 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | NorthStar Rx LLC | 16714-633 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | NorthStar Rx LLC | 16714-632 |