What is NDC 69238-2016?

69238-2016 is the product NDC for Ipratropium Bromide, Ipratropium bromide 21 ug/1 spray, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ipratropium Bromide NDC 69238-2016 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-2016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-2016Add 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
69238-2016-3	69238201603	1 BOTTLE, SPRAY in 1 CARTON (69238-2016-3) / 345 SPRAY in 1 BOTTLE, SPRAYMarketed from Aug 18, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 21 ug/1
Dosage form: Spray
Route: Nasal
Labeler: Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215104
Marketing start: Aug 18, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 69238-2016_1c1d7d62-9ebf-49eb-9eb2-471f9ce73637SPL ID 1c1d7d62-9ebf-49eb-9eb2-471f9ce73637SPL set ID 61820346-29d9-4864-b8f4-4a198b8ac594RxCUI 1797833UNII J697UZ2A9JUPC 0369238201635
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

N469238201603 followed by a unit qualifier and the quantity

Package 69238-2016-03. 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 Dec 30, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ipratropium Bromide Nasal Solution 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Ipratropium Bromide Nasal Solution 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-2016

What is NDC 69238-2016?: 69238-2016 is the product NDC for Ipratropium Bromide, Ipratropium bromide 21 ug/1 spray, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, 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?: Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ipratropium Bromide	Ipratropium bromide .5 mg/2.5mL	SolutionRespiratory (Inhalation)	Cardinal Health 107, LLC	55154-4411	55154-4411-05
Ipratropium Bromide	Ipratropium bromide 21 ug/1	Spray, MeteredNasal	Lupin Pharmaceuticals, Inc.	70748-336	70748-0336-01
Ipratropium Bromide	Ipratropium bromide 42 ug/1	Spray, MeteredNasal	Lupin Pharmaceuticals, Inc.	70748-337	70748-0337-01
Ipratropium Bromide	Ipratropium bromide 42 ug/1	Spray, MeteredNasal	Sportpharm LLC	85766-242	85766-0242-15
Ipratropium Bromide	Ipratropium bromide 42 ug/1	Spray, MeteredNasal	Oceanside Pharmaceuticals	68682-399	68682-0399-15
Ipratropium Bromide	Ipratropium bromide .5 mg/2.5mL	SolutionRespiratory (Inhalation)	Rising Pharma Holdings, Inc.	64980-640	64980-0640-0264980-0640-0364980-0640-06
Ipratropium Bromide	Ipratropium bromide 21 ug/1	Spray, MeteredNasal	Advagen Pharma Ltd	72888-149	72888-0149-38
Ipratropium Bromide	Ipratropium bromide 42 ug/1	Spray, MeteredNasal	Advagen Pharma Ltd	72888-148	72888-0148-37
Ipratropium Bromide	Ipratropium bromide 42 ug/1	SprayNasal	Amneal Pharmaceuticals NY LLC	69238-2017	69238-2017-02
Ipratropium Bromide	Ipratropium bromide 21 ug/1	Spray, MeteredNasal	NORTHSTAR RX LLC	16714-526	16714-0526-01

All 33 Ipratropium Bromide NDCs