Ipratropium Bromide
- Product NDC
- 69238-2016
- 11-digit product format
- 692382016
- Labeler code
- 69238
- Product ID
- 69238-2016_1c1d7d62-9ebf-49eb-9eb2-471f9ce73637
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ipratropium Bromide
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA215104
- Marketing category
- ANDA
- Marketing start
- 2022-08-18
- Substance
- IPRATROPIUM BROMIDE
- Active strength
- 21 ug/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ipratropium Bromide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IPRATROPIUM BROMIDE | 21 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J697UZ2A9J |
| Rxcui | 1797833 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-2016-3 | Ipratropium Bromide | 345 in 1 BOTTLE, SPRAY | SPRAY | 345 | | 10 |
| 69238-2016-3 | Ipratropium Bromide | 1 in 1 CARTON | SPRAY | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-2016 | IPRATROPIUM BROMIDE SPRAY [AMNEAL PHARMACEUTICALS NY LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20231231_61820346-29d9-4864-b8f4-4a198b8ac594.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69238-2016-3 | 69238201603 | 1 BOTTLE, SPRAY in 1 CARTON (69238-2016-3) / 345 SPRAY in 1 BOTTLE, SPRAY | 2022-08-18 | 0000-00-00 | No | No | Current |