Ipratropium Bromide
- Product NDC
- 68071-3769
- 11-digit product format
- 680713769
- Labeler code
- 68071
- Product ID
- 68071-3769_2b9b4fba-8f83-9fe1-e063-6294a90a9747
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ipratropium Bromide
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA075693
- Marketing category
- ANDA
- Marketing start
- 2010-11-09
- Substance
- IPRATROPIUM BROMIDE
- Active strength
- .5 mg/2.5mL
- 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 | .5 mg/2.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J697UZ2A9J |
| Rxcui | 836358 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3769-2 | Ipratropium Bromide | 25 in 1 POUCH | SOLUTION | 25 | | 1 |
| 68071-3769-2 | Ipratropium Bromide | 2.5 mL in 1 AMPULE | SOLUTION | 2.5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3769 | IPRATROPIUM BROMIDE SOLUTION [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20250115_2b9b619a-5e2a-73ef-e063-6394a90a97fe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3769-2 | 68071376902 | 25 AMPULE in 1 POUCH (68071-3769-2) / 2.5 mL in 1 AMPULE | 25 ampule | 2025-01-13 | No | No | Current |