Ipratropium Bromide
- Product NDC
- 0591-3798
- 11-digit product format
- 005913798
- Labeler code
- 0591
- Product ID
- 0591-3798_cdc5d8b0-a363-4896-996c-10a592370db9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ipratropium Bromide
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA075693
- Marketing category
- ANDA
- Marketing start
- 2011-03-01
- Marketing end
- 2022-04-30
- Substance
- IPRATROPIUM BROMIDE
- Active strength
- 1 mg/2.5mL
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36c | Product name | 2 | 20251106 |
| d953267a-4ca0-4d44-91ad-712cdee8ab38 | Product name | 2 | 20250630 |
| 0a278166-c8aa-41b6-b4a5-6ac332bde76a | Product name | 1 | 20230718 |
| 6ac73021-459f-435b-b6c5-8c7d6a50c021 | Product name | 2 | 20170404 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3798-30 | ML - Milliliter | 0591-3798 | 0ce7c849-95b4-443a-a0c7-de5fb378c697 | 1 | 2012-07-24 |
| 0591-3798-60 | ML - Milliliter | 0591-3798 | c0af4c9a-57a0-4a4d-9cd6-aa7d19cf4e87 | 1 | 2012-07-24 |
| 0591-3798-83 | ML - Milliliter | 0591-3798 | ba98e452-fc74-442f-b42a-2a3efc95f207 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| IPRATROPIUM BROMIDE | ACTIVE INGREDIENT | J697UZ2A9J | IPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| IPRATROPIUM | ACTIVE MOIETY | GR88G0I6UL | IPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | IPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 836358 | ipratropium bromide 0.02 % Inhalation Solution | PSN | 95990ec1-9cfd-4b94-afbd-7ced6ecca567 | 1 |
| 836358 | ipratropium bromide 0.2 MG/ML Inhalation Solution | SCD | 95990ec1-9cfd-4b94-afbd-7ced6ecca567 | 1 |
| 836358 | ipratropium bromide 0.02 % Inhalation Solution | SY | 95990ec1-9cfd-4b94-afbd-7ced6ecca567 | 1 |
| 836358 | ipratropium bromide 0.5 MG per 2.5 ML Inhalation Solution | SY | 95990ec1-9cfd-4b94-afbd-7ced6ecca567 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-3798-30 | 00591379830 | 1 POUCH in 1 CARTON (0591-3798-30) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL | 1 pouch | 2011-03-01 | 0000-00-00 | No | No | Current |
| 0591-3798-60 | 00591379860 | 2 POUCH in 1 CARTON (0591-3798-60) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL | 2 pouch | 2011-03-01 | 0000-00-00 | No | No | Current |
| 0591-3798-83 | 00591379883 | 1 POUCH in 1 CARTON (0591-3798-83) > 25 VIAL in 1 POUCH > 2.5 mL in 1 VIAL | 1 pouch | 2011-03-01 | 0000-00-00 | No | No | Current |