NDC codes

FDA NDC Directory
Product NDC (as listed)64980-640Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0640Add 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
64980-640-02649800640021 POUCH in 1 CARTON (64980-640-02) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 25, 2025
64980-640-03649800640031 POUCH in 1 CARTON (64980-640-03) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 25, 2025
64980-640-06649800640062 POUCH in 1 CARTON (64980-640-06) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 25, 2025

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)
Ipratropium Bromide
Generic name (nonproprietary)
ipratropium bromide
Active ingredients
Ipratropium bromide — .5 mg/2.5mL
Dosage form
Solution
Route
Respiratory (Inhalation)
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075562
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 64980-640_56c00859-cb3c-8f7f-e063-6394a90aaf67SPL ID 56c00859-cb3c-8f7f-e063-6394a90aaf67SPL set ID 3249aea8-a395-f09f-e063-6294a90a2d8bRxCUI 836358UNII J697UZ2A9JUPC 0364980640008
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 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.

NDC on a medical claim

N464980064002 followed by a unit qualifier and the quantity

Package 64980-0640-02. 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)

INDICATIONS AND USAGE Ipratropium bromide inhalation solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075562

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

FDA NDC Directory listings under ANDA 075562
ProductStrengthForm · routeLabelerProduct NDC
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)Chartwell RX, LLC62135-830
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)Nephron Pharmaceuticals Corporation0487-9801

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