Prescription drug · ANDA
Ipratropium Bromide NDC 50090-5968
Ipratropium bromide 42 ug/1 · Spray, Metered · Nasal · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5968-0 | 5009059680050090596800 | 1 BOTTLE, PUMP in 1 CARTON (50090-5968-0) / 165 SPRAY, METERED in 1 BOTTLE, PUMPMarketed from Apr 28, 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 — 42 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-5968_f8b56135-aaa3-4dc0-8f86-3f23e299ba7eSPL ID f8b56135-aaa3-4dc0-8f86-3f23e299ba7eSPL set ID 411ccc2c-ec30-450d-8704-b63095fd343bRxCUI 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
N450090596800followed by a unit qualifier and the quantityPackage 50090-5968-00. 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.
About NDC 50090-5968
- What is NDC 50090-5968?
- 50090-5968 is the product NDC for Ipratropium Bromide, Ipratropium bromide 42 ug/1 spray, metered, listed with the FDA by A-S Medication Solutions. 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?
- A-S Medication Solutions, NDC labeler code 50090. 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.
Related NDCs: other Ipratropium Bromide products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 21 ug/1 | SprayNasal | Amneal Pharmaceuticals NY LLC | 69238-2016 | 69238-2016-03 |
| Ipratropium Bromide | Ipratropium bromide 42 ug/1 | SprayNasal | Amneal Pharmaceuticals NY LLC | 69238-2017 | 69238-2017-02 |
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 | NORTHSTAR RX LLC | 16714-527 |
| Ipratropium Bromide | Ipratropium bromide 42 ug/1 | Spray, MeteredNasal | Apotex Corp. | 60505-0827 |