Prescription drug · ANDA
Ibandronate Sodium NDC 33342-150
Ibandronate sodium 150 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-150-52 | 33342015052 | 1 BLISTER PACK in 1 CARTON (33342-150-52) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 1, 2025 | |
| 33342-150-53 | 33342015053 | 3 CARTON in 1 BOX (33342-150-53) / 1 BLISTER PACK in 1 CARTON (33342-150-01) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 13, 2018 |
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)
- Ibandronate Sodium
- Generic name (nonproprietary)
- ibandronate sodium
- Active ingredients
- Ibandronate sodium — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206887
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 33342-150_29367df4-fac5-4117-963c-3e40ed998461SPL ID 29367df4-fac5-4117-963c-3e40ed998461SPL set ID a5741ef6-0599-4657-8cda-2902ded4f680RxCUI 904932UNII J12U072QL0
- 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
N433342015052followed by a unit qualifier and the quantityPackage 33342-0150-52. 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)
Ibandronate sodium is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. ( 1.1 ). Limitations of Use The 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. ( 1.2 ) 1.1 Treatment and Prevention of Postmenopausal Osteoporosis Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium tablets increases bone mineral density (BMD) and reduce the incidence of vertebral fractures. 1.2 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectivenes…
Excerpt only. Read the full label for complete information.
About NDC 33342-150
- What is NDC 33342-150?
- 33342-150 is the product NDC for Ibandronate Sodium, Ibandronate sodium 150 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibandronate Sodium.
- What is the active ingredient?
- Ibandronate sodium.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibandronate Sodium?
- 7 other product NDCs are listed under this name. See all Ibandronate Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibandronate 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) |
|---|---|---|---|---|---|
| Ibandronate Sodium | Ibandronate sodium 150 mg/1 | TabletOral | Bionpharma Inc. | 69452-378 | 69452-0378-74 |
| Ibandronate Sodium | Ibandronate sodium 3 mg/3mL | InjectionIntravenous | Apotex Corp. | 60505-6097 | 60505-6097-00 |
| Ibandronate Sodium | Ibandronate sodium 3 mg/3mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-191 | 55150-0191-83 |
| Ibandronate Sodium | Ibandronate sodium 3 mg/3mL | Injection, SolutionIntravenous | Sun Pharmaceutical Industries, Inc. | 62756-218 | 62756-0218-40 |
| Ibandronate sodium | Ibandronate sodium 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-7654 | 50090-7654-00 |
| Ibandronate sodium | Ibandronate sodium 150 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-575 | 55111-0575-0355111-0575-43 |
| Ibandronate Sodium | Ibandronate sodium 150 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-643 | 60429-0643-73 |