Prescription drug · ANDA
Ipratropium Bromide NDC 72162-2144
Ipratropium bromide 42 ug/1 · Spray · Nasal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2144-2 | 72162214402 | 1 BOTTLE, SPRAY in 1 CARTON (72162-2144-2) / 165 SPRAY in 1 BOTTLE, SPRAYMarketed from Dec 7, 2023 |
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 — 42 ug/1
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076598
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 72162-2144_62a2d09a-885e-4b77-be25-e68d409e5db6SPL ID 62a2d09a-885e-4b77-be25-e68d409e5db6SPL set ID 43ef9085-64e4-429a-a614-926d9a3652b7RxCUI 1797844UNII 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
N472162214402followed by a unit qualifier and the quantityPackage 72162-2144-02. 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 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of ipratropium bromide 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076598
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 42 ug/1 | SprayNasal | Hikma Pharmaceuticals USA Inc. | 0054-0046 |