Albuterol Sulfate
- Product NDC
- 64980-643
- 11-digit product format
- 649800643
- Labeler code
- 64980
- Product ID
- 64980-643_3301695d-8226-0f9b-e063-6394a90a9582
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Rising Pharma Holdings, Inc
- Application
- ANDA076355
- Marketing category
- ANDA
- Marketing start
- 2025-04-14
- Substance
- ALBUTEROL SULFATE
- Active strength
- .63 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 | .63 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 |
|---|
| 64980-643-03 | Albuterol Sulfate | 1 in 1 POUCH | SOLUTION | 1 | | 2 |
| 64980-643-03 | Albuterol Sulfate | 30 in 1 CARTON | SOLUTION | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-643 | ALBUTEROL SULFATE SOLUTION [RISING PHARMA HOLDINGS, INC] | 2 | Current NDC, 2 package rows | 20250419_32474c0e-af35-69d1-e063-6394a90a53c6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64980-643-03 | 64980064303 | 30 POUCH in 1 CARTON (64980-643-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 30 pouch | 2025-04-30 | No | No | Current |