NDC codes

FDA NDC Directory
Product NDC (as listed)0093-3100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-3100Add 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 NDC11-digit (billing)PackageCopy
0093-3100-56000933100560009331005630 TABLET, FILM COATED in 1 BOTTLE (0093-3100-56)Marketed from Jun 1, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 monohydrate — 30 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077132
Marketing start
Listing expires
Other FDA classes
Diphosphonates (Chemical structure)
Identifiers
Product ID 0093-3100_641c2a59-be2b-4246-8990-b7bf563012beSPL ID 641c2a59-be2b-4246-8990-b7bf563012beSPL set ID dddcd321-4d2e-4643-bf3c-7b752b33ba39RxCUI 905024, 905032, 905041, 905092, 905100UNII F67L43UT5C
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

N400093310056 followed by a unit qualifier and the quantity

Package 00093-3100-56. 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 tablets are 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 are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets reduce the…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-3100

What is NDC 0093-3100?
0093-3100 is the product NDC for Risedronate Sodium, Risedronate sodium monohydrate 30 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, 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 monohydrate.
Who is the labeler?
Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Risedronate SodiumRisedronate sodium 35 mg/1Tablet, Delayed releaseOralSun Pharmaceutical Industires Inc.63304-44063304-0440-09
Risedronate SodiumRisedronate sodium hemi-pentahydrate 35 mg/1Tablet, Film coatedOralHangzhou Minsheng Binjiang Pharmaceutical CO., Ltd60723-04160723-0041-0460723-0041-12
Risedronate SodiumRisedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1Tablet, Delayed releaseOralMylan Pharmaceuticals, Inc.59762-040759762-0407-04
Risedronate SodiumRisedronate sodium 150 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-87065862-0870-0365862-0870-11
Risedronate SodiumRisedronate sodium 5 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-10733342-0107-0633342-0107-0733342-0107-49
Risedronate SodiumRisedronate sodium 30 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-10833342-0108-0633342-0108-0733342-0108-15
Risedronate SodiumRisedronate sodium 35 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-10933342-0109-3733342-0109-50
risedronate sodiumRisedronate sodium hemi-pentahydrate 5 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-66647335-0666-0847335-0666-1847335-0666-83+1 more
risedronate sodiumRisedronate sodium hemi-pentahydrate 30 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-66747335-0667-0847335-0667-1847335-0667-83+1 more
risedronate sodiumRisedronate sodium hemi-pentahydrate 35 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-66847335-0668-6247335-0668-68

All 23 Risedronate Sodium NDCs

Other NDCs under ANDA 077132

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

FDA NDC Directory listings under ANDA 077132
ProductStrengthForm · routeLabelerProduct NDC
Risedronate SodiumRisedronate sodium monohydrate 35 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-3098
Risedronate SodiumRisedronate sodium monohydrate 5 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-3099

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