What is NDC 33342-109?

33342-109 is the product NDC for Risedronate Sodium, Risedronate sodium 35 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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Risedronate Sodium NDC 33342-109 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-109Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0109Add 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
33342-109-37	3334201093733342010937	1 BLISTER PACK in 1 CARTON (33342-109-37) / 4 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 9, 2015
33342-109-50	3334201095033342010950	3 BLISTER PACK in 1 CARTON (33342-109-50) / 4 TABLET, FILM COATED in 1 BLISTER PACKMarketed 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 — 35 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: Dec 9, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Diphosphonates (Chemical structure)
Identifiers: Product ID 33342-109_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

N433342010937 followed by a unit qualifier and the quantity

Package 33342-0109-37. 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 Mar 1, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 33342-109

What is NDC 33342-109?: 33342-109 is the product NDC for Risedronate Sodium, Risedronate sodium 35 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?: 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Risedronate Sodium NDCs
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 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 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

All 23 Risedronate Sodium NDCs

Other NDCs under ANDA 203533

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203533
Product	Strength	Form · route	Labeler	Product NDC
Risedronate Sodium	Risedronate sodium 5 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-107
Risedronate Sodium	Risedronate sodium 30 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-108