NDC codes

FDA NDC Directory
Product NDC (as listed)68682-398Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68682-0398Add 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
68682-398-3068682039830686820398301 BOTTLE, SPRAY in 1 CARTON (68682-398-30) / 345 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Jun 1, 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)
Ipratroprium Bromide
Generic name (nonproprietary)
ipratroprium bromide
Active ingredients
Ipratropium bromide — 21 ug/1
Dosage form
Spray, Metered
Route
Nasal
Labeler
Oceanside PharmaceuticalsNDC labeler code 68682
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076025
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 68682-398_b9d78453-9a78-4777-908f-a46a34f09cb1SPL ID b9d78453-9a78-4777-908f-a46a34f09cb1SPL set ID 40e37c2f-a2c0-419b-8451-1aa0458bc420RxCUI 1797833UNII 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 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

N468682039830 followed by a unit qualifier and the quantity

Package 68682-0398-30. 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 Nasal Solution 0.03% (Nasal Spray) 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% (Nasal Spray) 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 68682-398

What is NDC 68682-398?
68682-398 is the product NDC for Ipratroprium Bromide, Ipratropium bromide 21 ug/1 spray, metered, listed with the FDA by Oceanside Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ipratroprium Bromide.
What is the active ingredient?
Ipratropium bromide.
Who is the labeler?
Oceanside Pharmaceuticals, NDC labeler code 68682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ipratroprium Bromide?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 076025

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

FDA NDC Directory listings under ANDA 076025
ProductStrengthForm · routeLabelerProduct NDC
Ipratropium bromideIpratropium bromide 21 ug/1Spray, MeteredNasalBausch & Lomb Incorporated24208-398

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