Ipratropium Bromide
- Product NDC
- 16714-527
- 11-digit product format
- 167140527
- Labeler code
- 16714
- Product ID
- 16714-527_1ada81c7-04e0-f9ec-8995-d0aa5c19b678
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ipratropium bromide
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- NORTHSTAR RX LLC
- Application
- ANDA076155
- Marketing category
- ANDA
- Marketing start
- 2022-02-22
- Substance
- IPRATROPIUM BROMIDE
- Active strength
- 42 ug/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ipratropium Bromide
- Listing expiration
- 2027-12-31
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 |
|---|
| 16714-527-01 | Ipratropium Bromide | 1 in 1 CARTON | SPRAY, METERED | 1 | | 5 |
| 16714-527-01 | Ipratropium Bromide | 165 in 1 BOTTLE, PUMP | SPRAY, METERED | 165 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-527 | IPRATROPIUM BROMIDE SPRAY, METERED [NORTHSTAR RX LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240927_e592b6b5-038a-dbe8-457e-76e88a0f194a.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 |
|---|
| 16714-527-01 | 16714052701 | 1 BOTTLE, PUMP in 1 CARTON (16714-527-01) / 165 SPRAY, METERED in 1 BOTTLE, PUMP | 2022-02-22 | 0000-00-00 | No | No | Current |