NDC codes

FDA NDC Directory
Product NDC (as listed)65862-905Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0905Add 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
65862-905-036586209050330 POUCH in 1 CARTON (65862-905-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-01) / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 27, 2016
65862-905-25658620905251 POUCH in 1 CARTON (65862-905-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 27, 2016
65862-905-30658620905301 POUCH in 1 CARTON (65862-905-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-33) / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 27, 2016
65862-905-60658620905602 POUCH in 1 CARTON (65862-905-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 27, 2016

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)
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206543
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 65862-905_08eada61-404a-b5f8-e063-6294a90a74e7SPL ID 08eada61-404a-b5f8-e063-6294a90a74e7SPL set ID ff2b6bda-4acd-41fd-8970-458c5265df21RxCUI 836358UNII 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 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

N465862090503 followed by a unit qualifier and the quantity

Package 65862-0905-03. 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)

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)

About NDC 65862-905

What is NDC 65862-905?
65862-905 is the product NDC for Ipratropium bromide, Ipratropium bromide .5 mg/2.5mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ipratropium bromide.
What is the active ingredient?
Ipratropium bromide.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ipratropium bromide?
32 other product NDCs are listed under this name. See all Ipratropium bromide 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 Ipratropium bromide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)Cardinal Health 107, LLC55154-441155154-4411-05
Ipratropium BromideIpratropium bromide 21 ug/1Spray, MeteredNasalLupin Pharmaceuticals, Inc.70748-33670748-0336-01
Ipratropium BromideIpratropium bromide 42 ug/1Spray, MeteredNasalLupin Pharmaceuticals, Inc.70748-33770748-0337-01
Ipratropium BromideIpratropium bromide 42 ug/1Spray, MeteredNasalSportpharm LLC85766-24285766-0242-15
Ipratropium BromideIpratropium bromide 42 ug/1Spray, MeteredNasalOceanside Pharmaceuticals68682-39968682-0399-15
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)Rising Pharma Holdings, Inc.64980-64064980-0640-0264980-0640-0364980-0640-06
Ipratropium BromideIpratropium bromide 21 ug/1Spray, MeteredNasalAdvagen Pharma Ltd72888-14972888-0149-38
Ipratropium BromideIpratropium bromide 42 ug/1Spray, MeteredNasalAdvagen Pharma Ltd72888-14872888-0148-37
Ipratropium BromideIpratropium bromide 21 ug/1SprayNasalAmneal Pharmaceuticals NY LLC69238-201669238-2016-03
Ipratropium BromideIpratropium bromide 42 ug/1SprayNasalAmneal Pharmaceuticals NY LLC69238-201769238-2017-02

All 33 Ipratropium bromide NDCs

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