NDC codes

FDA NDC Directory
Product NDC (as listed)76204-100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76204-0100Add 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
76204-100-01762040100017620401000130 POUCH in 1 CARTON (76204-100-01) / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULEMarketed from Nov 21, 2011
76204-100-2576204010025762040100251 POUCH in 1 CARTON (76204-100-25) / 25 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULEMarketed from Nov 21, 2011
76204-100-3076204010030762040100301 POUCH in 1 CARTON (76204-100-30) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULEMarketed from Nov 21, 2011
76204-100-6076204010060762040100602 POUCH in 1 CARTON (76204-100-60) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULEMarketed from Nov 21, 2011

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
Ritedose Pharmaceuticals, LLCNDC labeler code 76204
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075693
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 76204-100_459b984d-b299-c7c0-e063-6294a90a3efdSPL ID 459b984d-b299-c7c0-e063-6294a90a3efdSPL set ID 22479633-624a-4251-ad3c-1dcba5d503fbRxCUI 836358UNII J697UZ2A9JUPC 0376204100250, 0376204100014
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

N476204010001 followed by a unit qualifier and the quantity

Package 76204-0100-01. 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)

About NDC 76204-100

What is NDC 76204-100?
76204-100 is the product NDC for Ipratropium Bromide, Ipratropium bromide .5 mg/2.5mL solution, listed with the FDA by Ritedose Pharmaceuticals, LLC. 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?
Ritedose Pharmaceuticals, LLC, NDC labeler code 76204. 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

Other NDCs under ANDA 075693

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

FDA NDC Directory listings under ANDA 075693
ProductStrengthForm · routeLabelerProduct NDC
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)Mylan Pharmaceuticals Inc.0378-7970
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)A-S Medication Solutions50090-0668
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)A-S Medication Solutions50090-6373
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)Cardinal Health 107, LLC55154-2134
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)Cardinal Health 107, LLC55154-4411
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)American Health Packaging60687-394
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)Redpharm Drug67296-2246
Ipratropium BromideIpratropium bromide .5 mg/2.5mLSolutionRespiratory (Inhalation)NuCare Pharmaceuticals, Inc.68071-3769

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