Risedronate Sodium NDC 63304-440

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-440Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0440Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
63304-440-09	63304044009	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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203925
Marketing start: Jul 10, 2019
Listing expires: Dec 31, 2026
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

N463304044009 followed by a unit qualifier and the quantity

Package 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 Sep 9, 2020.

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.

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