NDC codes

FDA NDC Directory
Product NDC (as listed)55111-575Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0575Add 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
55111-575-0355111057503551110575033 BLISTER PACK in 1 CARTON (55111-575-03) / 1 TABLET in 1 BLISTER PACK (55111-575-11)Marketed from Jun 21, 2012
55111-575-4355111057543551110575431 BLISTER PACK in 1 CARTON (55111-575-43) / 3 TABLET in 1 BLISTER PACK (55111-575-13)Marketed from Nov 20, 2021

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)
Ibandronate sodium
Generic name (nonproprietary)
ibandronate sodium
Active ingredients
Ibandronate sodium — 150 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078997
Marketing start
Listing expires
Other FDA classes
Diphosphonates (Chemical structure)
Identifiers
Product ID 55111-575_f38ea198-a3dd-aef9-b467-56ecfef1bc39SPL ID f38ea198-a3dd-aef9-b467-56ecfef1bc39SPL set ID f94d9c49-245a-8081-42c4-785113fce498RxCUI 904932UNII J12U072QL0
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

N455111057503 followed by a unit qualifier and the quantity

Package 55111-0575-03. 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)

Ibandronate sodium tablet is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. (1.1) Limitations of Use The 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 Treatment and Prevention of Postmenopausal Osteoporosis Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium tablets increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. 1.2 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiv…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-575

What is NDC 55111-575?
55111-575 is the product NDC for Ibandronate sodium, Ibandronate sodium 150 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ibandronate sodium.
What is the active ingredient?
Ibandronate sodium.
Who is the labeler?
Dr. Reddy's Laboratories Limited, NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ibandronate sodium?
8 other product NDCs are listed under this name. See all Ibandronate 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 Ibandronate sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ibandronate SodiumIbandronate sodium 150 mg/1TabletOralBionpharma Inc.69452-37869452-0378-74
Ibandronate SodiumIbandronate sodium 150 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-15033342-0150-5233342-0150-53
Ibandronate SodiumIbandronate sodium 150 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-23765862-0237-03
Ibandronate SodiumIbandronate sodium 3 mg/3mLInjectionIntravenousApotex Corp.60505-609760505-6097-00
Ibandronate SodiumIbandronate sodium 3 mg/3mLInjection, SolutionIntravenousEugia US LLC55150-19155150-0191-83
Ibandronate SodiumIbandronate sodium 3 mg/3mLInjection, SolutionIntravenousSun Pharmaceutical Industries, Inc.62756-21862756-0218-40
Ibandronate sodiumIbandronate sodium 150 mg/1TabletOralA-S Medication Solutions50090-765450090-7654-00
Ibandronate SodiumIbandronate sodium 150 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-64360429-0643-73

Other NDCs under ANDA 078997

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

FDA NDC Directory listings under ANDA 078997
ProductStrengthForm · routeLabelerProduct NDC
Ibandronate sodiumIbandronate sodium 150 mg/1TabletOralA-S Medication Solutions50090-7654

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