Ipratropium Bromide NDC 0054-0046

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0046Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0046Add 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
0054-0046-41	00054004641	1 BOTTLE, SPRAY in 1 CARTON (0054-0046-41) / 165 SPRAY in 1 BOTTLE, SPRAYMarketed from Nov 5, 2003

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): Ipratropium Bromide
Generic name (nonproprietary): ipratropium bromide
Active ingredients: Ipratropium bromide — 42 ug/1
Dosage form: Spray
Route: Nasal
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076598
Marketing start: Nov 5, 2003
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 0054-0046_1af1d74f-a67d-450a-ab96-1021079f5a35SPL ID 1af1d74f-a67d-450a-ab96-1021079f5a35SPL set ID 71bdbbb9-8696-416d-bed4-7259929c0161RxCUI 1797844UNII J697UZ2A9J
Pharmacologic class: Anticholinergic

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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400054004641 followed by a unit qualifier and the quantity

Package 00054-0046-41. 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 Jul 1, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ipratropium bromide nasal solution 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of ipratropium bromide 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076598

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

FDA NDC Directory listings under ANDA 076598
Product	Strength	Form · route	Labeler	Product NDC
Ipratropium Bromide	Ipratropium bromide 42 ug/1	SprayNasal	Bryant Ranch Prepack	72162-2144