Ipratropium Bromide
- Product NDC
- 53217-008
- 11-digit product format
- 532170008
- Labeler code
- 53217
- Product ID
- 53217-008_3a79526b-bcfe-4635-82a6-73cafe9b13eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ipratropium Bromide
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA075693
- Marketing category
- ANDA
- Marketing start
- 2011-02-01
- Marketing end
- 0000-00-00
- Substance
- IPRATROPIUM BROMIDE
- Active strength
- 1 mg/2.5mL
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53217-008-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fa9f-f424-e053-dadaa90a57ce | IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53217-008-01 | Ipratropium Bromide | 30 in 1 POUCH | SOLUTION | 30 | 1 | |
| 53217-008-01 | Ipratropium Bromide | 2 in 1 CARTON | SOLUTION | 2 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53217-008-01 | ML - Milliliter | 53217-008 | de44b5ea-c4fa-4aa7-bac5-24a15dacc244 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| IPRATROPIUM BROMIDE | ACTIVE INGREDIENT | J697UZ2A9J | IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| IPRATROPIUM | ACTIVE MOIETY | GR88G0I6UL | IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IPRATROPIUM BROMIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 836358 | ipratropium bromide 0.02 % Inhalation Solution | PSN | 769febba-671d-476b-b0c8-71489a2f9d20 | 1 |
| 836358 | ipratropium bromide 0.2 MG/ML Inhalation Solution | SCD | 769febba-671d-476b-b0c8-71489a2f9d20 | 1 |
| 836358 | ipratropium bromide 0.02 % Inhalation Solution | SY | 769febba-671d-476b-b0c8-71489a2f9d20 | 1 |
| 836358 | ipratropium bromide 0.5 MG per 2.5 ML Inhalation Solution | SY | 769febba-671d-476b-b0c8-71489a2f9d20 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53217-008-01 | 53217000801 | 30 in 1 POUCH | Historical |