Ipratropium Bromide
- Product NDC
- 47335-706
- 11-digit product format
- 473350706
- Labeler code
- 47335
- Product ID
- 47335-706_147b55d9-c9f9-4a22-814a-acf834a1864d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ipratropium Bromide
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA207903
- Marketing category
- ANDA
- Marketing start
- 2020-02-04
- 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 |
|---|
| 47335-706-48 | Ipratropium Bromide | 2.5 mL in 1 VIAL | SOLUTION | 2.5 | | 5 |
| 47335-706-48 | Ipratropium Bromide | 5 in 1 POUCH | SOLUTION | 5 | | 5 |
| 47335-706-49 | Ipratropium Bromide | 5 in 1 CARTON | SOLUTION | 5 | | 5 |
| 47335-706-52 | Ipratropium Bromide | 6 in 1 CARTON | SOLUTION | 6 | | 5 |
| 47335-706-52 | Ipratropium Bromide | 5 in 1 POUCH | SOLUTION | 5 | | 5 |
| 47335-706-54 | Ipratropium Bromide | 12 in 1 CARTON | SOLUTION | 12 | | 5 |
| 47335-706-54 | Ipratropium Bromide | 5 in 1 POUCH | SOLUTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-706 | IPRATROPIUM BROMIDE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 5 | Current NDC, Legacy NDC, 7 package rows | 20220414_231ae8f2-1ec9-4e0f-90a8-11d7b6222576.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-706-48 | 47335070648 | 2.5 mL in 1 VIAL | 2.5 ml | | | | | Historical |
| 47335-706-49 | 47335070649 | 5 POUCH in 1 CARTON (47335-706-49) / 5 VIAL in 1 POUCH (47335-706-48) / 2.5 mL in 1 VIAL | 5 pouch | 2020-02-04 | 0000-00-00 | No | No | Current |
| 47335-706-52 | 47335070652 | 6 POUCH in 1 CARTON (47335-706-52) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL | 6 pouch | 2020-02-04 | 0000-00-00 | No | No | Current |
| 47335-706-54 | 47335070654 | 12 POUCH in 1 CARTON (47335-706-54) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL | 12 pouch | 2020-02-04 | 0000-00-00 | No | No | Current |