Prescription drug · ANDA
Ipratropium Bromide NDC 60505-0827
Ipratropium bromide 42 ug/1 · Spray, Metered · Nasal · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0827-1 | 60505082701 | 1 BOTTLE, PUMP in 1 CARTON (60505-0827-1) / 165 SPRAY, METERED in 1 BOTTLE, PUMPMarketed from May 26, 2020 |
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
- Apotex Corp.
- 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 60505-0827_043f1b19-c4cd-2936-a91d-8ad564701e1eSPL ID 043f1b19-c4cd-2936-a91d-8ad564701e1e
- 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
N460505082701followed by a unit qualifier and the quantityPackage 60505-0827-01. 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
The FDA listing for this product does not reference a label (SPL) set.
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 | A-S Medication Solutions | 50090-5968 |