NDC codes

FDA NDC Directory
Product NDC (as listed)55150-191Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55150-0191Add 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
55150-191-83551500191831 SYRINGE, GLASS in 1 CARTON (55150-191-83) / 3 mL in 1 SYRINGE, GLASSMarketed from Aug 19, 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)
Ibandronate Sodium
Generic name (nonproprietary)
ibandronate sodium
Active ingredients
Ibandronate sodium — 3 mg/3mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Eugia US LLCNDC labeler code 55150
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205332
Marketing start
Listing expires
Other FDA classes
Diphosphonates (Chemical structure)
Identifiers
Product ID 55150-191_9e93dc68-5558-4271-9f1f-44f4313babaeSPL ID 9e93dc68-5558-4271-9f1f-44f4313babaeSPL set ID e81f2c5b-bead-48ac-be3e-016cf963d7edRxCUI 904952UNII J12U072QL0UPC 0355150191833
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N455150019183 followed by a unit qualifier and the quantity

Package 55150-0191-83. 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 injection is a bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women. (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 Treatment of Postmenopausal Osteoporosis Ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [ see Clinical Studies (14) ] . 1.2 Important Limitations of Use The safety and effectiveness of ibandr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55150-191

What is NDC 55150-191?
55150-191 is the product NDC for Ibandronate Sodium, Ibandronate sodium 3 mg/3mL injection, solution, listed with the FDA by Eugia US LLC. It has 1 package NDC, 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?
Eugia US LLC, NDC labeler code 55150. 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?
7 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 3 mg/3mLInjectionIntravenousApotex Corp.60505-609760505-6097-00
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/1TabletOralDr. Reddy's Laboratories Limited55111-57555111-0575-0355111-0575-43
Ibandronate SodiumIbandronate sodium 150 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-64360429-0643-73

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in