Prescription drug · ANDA
Alendronate Sodium NDC 64980-340
Alendronate sodium 10 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-340-01 | 64980034001 | 100 TABLET in 1 BOTTLE (64980-340-01)Marketed from Aug 4, 2008 | |
| 64980-340-03 | 64980034003 | 30 TABLET in 1 BOTTLE (64980-340-03)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
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- 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 64980-340_ae2e410c-e759-4879-9b18-aba62f096312SPL ID ae2e410c-e759-4879-9b18-aba62f096312SPL set ID ffdd2496-d253-419b-85a6-8c615f7545f1RxCUI 904396, 904419, 904431UNII 2UY4M2U3RAUPC 0364980340038, 0364980342148, 0364980342018, 0364980340014
- 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
N464980034001followed by a unit qualifier and the quantityPackage 64980-0340-01. 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
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 are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets increases bone mass a…
Excerpt only. Read the full label for complete information.
About NDC 64980-340
- What is NDC 64980-340?
- 64980-340 is the product NDC for Alendronate Sodium, Alendronate sodium 10 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. 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?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 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 10 mg/1 | TabletOral | NorthStar Rx LLC | 16714-631 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | NorthStar Rx LLC | 16714-632 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | NorthStar Rx LLC | 16714-633 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | A-S Medication Solutions | 50090-3126 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | A-S Medication Solutions | 50090-5474 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | A-S Medication Solutions | 50090-5677 |
| Alendronate Sodium | Alendronate sodium 35 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-341 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-342 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-329 |
| Alendronate Sodium | Alendronate sodium 70 mg/1 | TabletOral | Proficient Rx LP | 71205-048 |