Prescription drug · ANDA
Ipratropium Bromide NDC 16714-527
Ipratropium bromide 42 ug/1 · Spray, Metered · Nasal · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-527-01 | 16714052701 | 1 BOTTLE, PUMP in 1 CARTON (16714-527-01) / 165 SPRAY, METERED in 1 BOTTLE, PUMPMarketed from Feb 22, 2022 |
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 — 42 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- NORTHSTAR RX LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076155
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 16714-527_1ada81c7-04e0-f9ec-8995-d0aa5c19b678SPL ID 1ada81c7-04e0-f9ec-8995-d0aa5c19b678SPL set ID e592b6b5-038a-dbe8-457e-76e88a0f194aRxCUI 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
N416714052701followed by a unit qualifier and the quantityPackage 16714-0527-01. 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 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 nasal solution, 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 nasal solution, 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 076155
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 | Spray, MeteredNasal | Apotex Corp. | 60505-0827 |
| Ipratropium Bromide | Ipratropium bromide 42 ug/1 | Spray, MeteredNasal | A-S Medication Solutions | 50090-5968 |