NDC codes

FDA NDC Directory
Product NDC (as listed)0487-9801Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00487-9801Add 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
0487-9801-010048798010130 POUCH in 1 CARTON (0487-9801-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 27, 2001
0487-9801-020048798010230 BAG in 1 BOX (0487-9801-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 27, 2001
0487-9801-25004879801251 POUCH in 1 CARTON (0487-9801-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 27, 2001
0487-9801-30004879801301 POUCH in 1 CARTON (0487-9801-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 27, 2001
0487-9801-60004879801602 POUCH in 1 CARTON (0487-9801-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 27, 2001

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 — .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 0487-9801_3249e47e-0ac1-e2a5-e063-6394a90a9993SPL ID 3249e47e-0ac1-e2a5-e063-6394a90a9993SPL set ID db8095db-d1fd-4099-9fb1-d1ad4e284976RxCUI 836358UNII J697UZ2A9JUPC 0304879801011, 0304879801004
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

N400487980101 followed by a unit qualifier and the quantity

Package 00487-9801-01. 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)Rising Pharma Holdings, Inc.64980-640
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)Chartwell RX, LLC62135-830

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