Prescription drug · ANDA
Alendronate (Alendronate sodium tablet) NDC 10135-718
Alendronate sodium 35 mg/1 · Tablet · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-718-12 | 10135071812 | 3 BLISTER PACK in 1 CARTON (10135-718-12) / 4 TABLET in 1 BLISTER PACKMarketed from Dec 1, 2020 | |
| 10135-718-44 | 10135071844 | 1 BLISTER PACK in 1 CARTON (10135-718-44) / 4 TABLET in 1 BLISTER PACKMarketed from Dec 1, 2020 |
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
- Generic name (nonproprietary)
- alendronate sodium tablet
- Active ingredients
- Alendronate sodium — 35 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc.NDC labeler code 10135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090258
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 10135-718_3e74abef-2742-2bbe-e063-6394a90a12cdSPL ID 3e74abef-2742-2bbe-e063-6394a90a12cdSPL set ID b63421af-ec03-1de7-e053-2a95a90abec6RxCUI 904396, 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
N410135071812followed by a unit qualifier and the quantityPackage 10135-0718-12. 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 increase bone mass an…
Excerpt only. Read the full label for complete information.
About NDC 10135-718
- What is NDC 10135-718?
- 10135-718 is the product NDC for Alendronate (alendronate sodium tablet), Alendronate sodium 35 mg/1 tablet, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alendronate (Alendronate sodium tablet).
- What is the active ingredient?
- Alendronate sodium.
- Who is the labeler?
- Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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?
- 3 other product NDCs are listed under this name. See all Alendronate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alendronate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alendronatealendronate sodium tablet | Alendronate sodium 70 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-719 | 10135-0719-1210135-0719-2010135-0719-44 |
| Alendronatealendronate sodium | Alendronate sodium 70 mg/1 | TabletOral | Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. | 60723-205 | 60723-0205-3160723-0205-3260723-0205-33 |
| Alendronatealendronate sodium | Alendronate sodium 35 mg/1 | TabletOral | Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. | 60723-207 | 60723-0207-3160723-0207-3260723-0207-33 |
Other NDCs under ANDA 090258
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 |
|---|---|---|---|---|
| Alendronatealendronate sodium tablet | Alendronate sodium 70 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-719 |
| Alendronatealendronate sodium | Alendronate sodium 70 mg/1 | TabletOral | Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. | 60723-205 |
| Alendronatealendronate sodium | Alendronate sodium 35 mg/1 | TabletOral | Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. | 60723-207 |