Albuterol Sulfate
- Product NDC
- 64980-641
- 11-digit product format
- 649800641
- Labeler code
- 64980
- Product ID
- 64980-641_325090e0-82fc-be8c-e063-6294a90a45a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA074880
- Marketing category
- ANDA
- Marketing start
- 2025-03-14
- Substance
- ALBUTEROL SULFATE
- Active strength
- 2.5 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 | 2.5 mg/3mL |
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 |
|---|
| 64980-641-02 | Albuterol Sulfate | 25 in 1 POUCH | SOLUTION | 25 | | 2 |
| 64980-641-02 | Albuterol Sulfate | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 64980-641-03 | Albuterol Sulfate | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 64980-641-03 | Albuterol Sulfate | 30 in 1 POUCH | SOLUTION | 30 | | 2 |
| 64980-641-06 | Albuterol Sulfate | 30 in 1 POUCH | SOLUTION | 30 | | 2 |
| 64980-641-06 | Albuterol Sulfate | 2 in 1 CARTON | SOLUTION | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-641 | ALBUTEROL SULFATE SOLUTION [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, 6 package rows | 20250411_32377c09-da6d-331c-e063-6294a90a7a46.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 |
|---|
| 64980-641-02 | 64980064102 | 1 POUCH in 1 CARTON (64980-641-02) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 1 pouch | 2025-03-14 | No | No | Historical |
| 64980-641-03 | 64980064103 | 1 POUCH in 1 CARTON (64980-641-03) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 1 pouch | 2025-03-14 | No | No | Historical |
| 64980-641-06 | 64980064106 | 2 POUCH in 1 CARTON (64980-641-06) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 2 pouch | 2025-03-14 | No | No | Historical |