Prescription drug · ANDA
Ipratroprium Bromide NDC 68682-398
Ipratropium bromide 21 ug/1 · Spray, Metered · Nasal · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-398-30 | 6868203983068682039830 | 1 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
N468682039830followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ipratropium bromide | Ipratropium bromide 21 ug/1 | Spray, MeteredNasal | Bausch & Lomb Incorporated | 24208-398 |