Prescription drug · ANDA
Risedronate Sodium NDC 33342-107
Risedronate sodium 5 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-107-06 | 3334201070633342010706 | 3 BLISTER PACK in 1 CARTON (33342-107-06) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 9, 2015 | |
| 33342-107-07 | 3334201070733342010707 | 30 TABLET, FILM COATED in 1 CONTAINER (33342-107-07)Marketed from Dec 9, 2015 | |
| 33342-107-49 | 3334201074933342010749 | 2000 TABLET, FILM COATED in 1 CONTAINER (33342-107-49)Marketed from Dec 9, 2015 |
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)
- Risedronate Sodium
- Generic name (nonproprietary)
- risedronate sodium
- Active ingredients
- Risedronate sodium — 5 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 203533
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 33342-107_56e83e0f-83f7-4039-a9b2-0d5ae251e2b1SPL ID 56e83e0f-83f7-4039-a9b2-0d5ae251e2b1SPL set ID 62aff8d6-a2f7-4c7e-a102-c70105ac3792RxCUI 905024, 905032, 905041, 905092, 905100UNII OFG5EXG60L
- 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
N433342010706followed by a unit qualifier and the quantityPackage 33342-0107-06. 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)
Risedronate sodium tablet, USP is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget's disease ( 1.4 ) 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. ( 1.5 ) 1.1 Postmenopausal Osteoporosis Risedronate sodium tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets, U…
Excerpt only. Read the full label for complete information.
About NDC 33342-107
- What is NDC 33342-107?
- 33342-107 is the product NDC for Risedronate Sodium, Risedronate sodium 5 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Risedronate Sodium.
- What is the active ingredient?
- Risedronate 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 Risedronate Sodium?
- 22 other product NDCs are listed under this name. See all Risedronate Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Risedronate 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) |
|---|---|---|---|---|---|
| Risedronate Sodium | Risedronate sodium 35 mg/1 | Tablet, Delayed releaseOral | Sun Pharmaceutical Industires Inc. | 63304-440 | 63304-0440-09 |
| Risedronate Sodium | Risedronate sodium hemi-pentahydrate 35 mg/1 | Tablet, Film coatedOral | Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd | 60723-041 | 60723-0041-0460723-0041-12 |
| Risedronate Sodium | Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1 | Tablet, Delayed releaseOral | Mylan Pharmaceuticals, Inc. | 59762-0407 | 59762-0407-04 |
| Risedronate Sodium | Risedronate sodium 150 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-870 | 65862-0870-0365862-0870-11 |
| Risedronate Sodium | Risedronate sodium 30 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-108 | 33342-0108-0633342-0108-0733342-0108-15 |
| Risedronate Sodium | Risedronate sodium 35 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-109 | 33342-0109-3733342-0109-50 |
| risedronate sodium | Risedronate sodium hemi-pentahydrate 5 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-666 | 47335-0666-0847335-0666-1847335-0666-83+1 more |
| risedronate sodium | Risedronate sodium hemi-pentahydrate 30 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-667 | 47335-0667-0847335-0667-1847335-0667-83+1 more |
| risedronate sodium | Risedronate sodium hemi-pentahydrate 35 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-668 | 47335-0668-6247335-0668-68 |
| Risedronate Sodium | Risedronate sodium 35 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3165 | 60505-3165-0060505-3165-02 |
Other NDCs under ANDA 203533
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 |
|---|---|---|---|---|
| Risedronate Sodium | Risedronate sodium 30 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-108 |
| Risedronate Sodium | Risedronate sodium 35 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-109 |