Albuterol Sulfate
- Product NDC
- 70518-3560
- 11-digit product format
- 705183560
- Labeler code
- 70518
- Product ID
- 70518-3560_4f59960f-dfa0-4c66-e063-6294a90adfbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- albuterol sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207857
- Marketing category
- ANDA
- Marketing start
- 2022-10-19
- Substance
- ALBUTEROL SULFATE
- Active strength
- .83 mg/mL
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Albuterol Sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALBUTEROL SULFATE | .83 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 021SEF3731 |
| Rxcui | 630208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3560-0 | Albuterol Sulfate | 12 in 1 CARTON | SOLUTION | 12 | | 6 |
| 70518-3560-0 | Albuterol Sulfate | 5 in 1 POUCH | SOLUTION | 5 | | 6 |
| 70518-3560-1 | Albuterol Sulfate | 5 in 1 CARTON | SOLUTION | 5 | | 6 |
| 70518-3560-1 | Albuterol Sulfate | 5 in 1 POUCH | SOLUTION | 5 | | 6 |
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 |
|---|
| 70518-3560-0 | 70518356000 | 12 POUCH in 1 CARTON (70518-3560-0) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL | 12 pouch | 2022-10-19 | 0000-00-00 | No | No | Current |
| 70518-3560-1 | 70518356001 | 5 POUCH in 1 CARTON (70518-3560-1) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL | 5 pouch | 2022-10-19 | | No | No | Historical |