Albuterol Sulfate
- Product NDC
- 62135-826
- 11-digit product format
- 621350826
- Labeler code
- 62135
- Product ID
- 62135-826_11e59625-431b-e530-e063-6294a90a0596
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Chartwell RX, LLC
- Application
- ANDA076355
- Marketing category
- ANDA
- Marketing start
- 2010-03-31
- 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 |
|---|
| 62135-826-84 | Albuterol Sulfate | 1 in 1 POUCH | SOLUTION | 1 | | 3 |
| 62135-826-84 | Albuterol Sulfate | 30 in 1 CARTON | SOLUTION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-826 | ALBUTEROL SULFATE SOLUTION [CHARTWELL RX, LLC] | 3 | Current NDC, 2 package rows | 20240222_4e48ccbe-3ec0-4bf2-be28-83eb9baa63d6.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 |
|---|
| 62135-826-84 | 62135082684 | 30 POUCH in 1 CARTON (62135-826-84) / 1 VIAL in 1 POUCH / 3 mL in 1 VIAL | 30 pouch | 2024-01-19 | No | No | Current |