Ipratropium Bromide
- Product NDC
- 0054-0046
- 11-digit product format
- 000540046
- Labeler code
- 0054
- Product ID
- 0054-0046_1af1d74f-a67d-450a-ab96-1021079f5a35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ipratropium Bromide
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA076598
- Marketing category
- ANDA
- Marketing start
- 2003-11-05
- Substance
- IPRATROPIUM BROMIDE
- Active strength
- 42 ug/1
- 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 | 42 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J697UZ2A9J |
| Rxcui | 1797844 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0046-41 | Ipratropium Bromide | 165 in 1 BOTTLE, SPRAY | SPRAY | 165 | | 11 |
| 0054-0046-41 | Ipratropium Bromide | 1 in 1 CARTON | SPRAY | 1 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IPRATROPIUM BROMIDE | ACTIVE INGREDIENT | J697UZ2A9J | IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] | 7 | |
| IPRATROPIUM | ACTIVE MOIETY | GR88G0I6UL | IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] | 7 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] | 7 | |
| EDETATE CALCIUM DISODIUM | INACTIVE INGREDIENT | 25IH6R4SGF | IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] | 7 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] | 7 | |
| HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) | INACTIVE INGREDIENT | 8136Y38GY5 | IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] | 7 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] | 7 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0046 | IPRATROPIUM BROMIDE SPRAY [HIKMA PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240209_71bdbbb9-8696-416d-bed4-7259929c0161.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0046-41 | 00054004641 | 1 BOTTLE, SPRAY in 1 CARTON (0054-0046-41) / 165 SPRAY in 1 BOTTLE, SPRAY | 2003-11-05 | 0000-00-00 | No | No | Current |