Prescription drug · ANDA
Risedronate Sodium NDC 63304-440
Risedronate sodium 35 mg/1 · Tablet, Delayed release · Oral · Sun Pharmaceutical Industires Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63304-440-09 | 6330404400963304044009 | 1 DOSE PACK in 1 CARTON (63304-440-09) / 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11)Marketed from Jul 10, 2019 |
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 — 35 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industires Inc.NDC labeler code 63304
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203925
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 63304-440_d97c9e6a-01e9-46ae-9088-0ca86b4eb842SPL ID d97c9e6a-01e9-46ae-9088-0ca86b4eb842SPL set ID 1d9e520b-2fa6-4603-b397-f0fc24fae775RxCUI 1020064, 1020065UNII 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
N463304044009followed by a unit qualifier and the quantityPackage 63304-0440-09. 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 delayed-release tablets are bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis (1.1) 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 (1.2). 1.1 Postmenopausal Osteoporosis Risedronate sodium delayed-release tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [ see Clinical Studies (14.1) ]. 1.2 Impo…
Excerpt only. Read the full label for complete information.
About NDC 63304-440
- What is NDC 63304-440?
- 63304-440 is the product NDC for Risedronate Sodium, Risedronate sodium 35 mg/1 tablet, delayed release, listed with the FDA by Sun Pharmaceutical Industires Inc.. It has 1 package NDC, 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?
- Sun Pharmaceutical Industires Inc., NDC labeler code 63304. 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 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 5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-107 | 33342-0107-0633342-0107-0733342-0107-49 |
| 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 |