Ipratroprium Bromide
- Product NDC
- 68682-398
- 11-digit product format
- 686820398
- Labeler code
- 68682
- Product ID
- 68682-398_b9d78453-9a78-4777-908f-a46a34f09cb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ipratroprium Bromide
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- ANDA076025
- Marketing category
- ANDA
- Marketing start
- 2025-06-01
- 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
- Ipratroprium 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 |
|---|
| 68682-398-30 | Ipratroprium Bromide | 345 in 1 BOTTLE, SPRAY | SPRAY, METERED | 345 | | 7 |
| 68682-398-30 | Ipratroprium Bromide | 1 in 1 CARTON | SPRAY, METERED | 1 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68682-398-30 | 68682039830 | 1 BOTTLE, SPRAY in 1 CARTON (68682-398-30) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY | 2025-06-01 | No | No | Current |