Albuterol Sulfate
- Product NDC
- 0378-7058
- 11-digit product format
- 003787058
- Labeler code
- 0378
- Product ID
- 0378-7058_de8e18d1-bd6b-484a-a7b4-3c286c8ae917
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA214531
- Marketing category
- ANDA
- Marketing start
- 2022-10-07
- Substance
- ALBUTEROL SULFATE
- Active strength
- 1.25 mg/3mL
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Albuterol Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALBUTEROL SULFATE | 1.25 mg/3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 021SEF3731 |
| Rxcui | 351136, 351137 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7058-52 | Albuterol Sulfate | 5 in 1 CARTON | SOLUTION | 5 | | 2 |
| 0378-7058-98 | Albuterol Sulfate | 3 mL in 1 VIAL | SOLUTION | 3 | | 2 |
| 0378-7058-98 | Albuterol Sulfate | 5 in 1 POUCH | SOLUTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7058 | ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 3 package rows | 20221029_9e6e982b-7dfe-45b8-aa76-754e8d2a8ef6.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 |
|---|
| 0378-7058-52 | 00378705852 | 5 POUCH in 1 CARTON (0378-7058-52) / 5 VIAL in 1 POUCH (0378-7058-98) / 3 mL in 1 VIAL | 5 pouch | 2022-10-07 | 0000-00-00 | No | No | Current |
| 0378-7058-98 | 00378705898 | 3 mL in 1 VIAL | 3 ml | | | | | Historical |