Ipratropium Bromide
- Product NDC
- 64980-640
- 11-digit product format
- 649800640
- Labeler code
- 64980
- Product ID
- 64980-640_3249a3d2-4951-f09b-e063-6294a90a9f79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ipratropium Bromide
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA075562
- Marketing category
- ANDA
- Marketing start
- 2025-04-25
- 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 |
|---|
| 64980-640-02 | Ipratropium Bromide | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 64980-640-02 | Ipratropium Bromide | 25 in 1 POUCH | SOLUTION | 25 | | 1 |
| 64980-640-03 | Ipratropium Bromide | 30 in 1 POUCH | SOLUTION | 30 | | 1 |
| 64980-640-03 | Ipratropium Bromide | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 64980-640-06 | Ipratropium Bromide | 2 in 1 CARTON | SOLUTION | 2 | | 1 |
| 64980-640-06 | Ipratropium Bromide | 30 in 1 POUCH | SOLUTION | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-640 | IPRATROPIUM BROMIDE SOLUTION [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 6 package rows | 20250427_3249aea8-a395-f09f-e063-6294a90a2d8b.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 |
|---|
| 64980-640-02 | 64980064002 | 1 POUCH in 1 CARTON (64980-640-02) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE | 1 pouch | 2025-04-25 | No | No | Current |
| 64980-640-03 | 64980064003 | 1 POUCH in 1 CARTON (64980-640-03) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE | 1 pouch | 2025-04-25 | No | No | Current |
| 64980-640-06 | 64980064006 | 2 POUCH in 1 CARTON (64980-640-06) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE | 2 pouch | 2025-04-25 | No | No | Current |