Albuterol Sulfate
- Product NDC
- 68788-8399
- 11-digit product format
- 687888399
- Labeler code
- 68788
- Product ID
- 68788-8399_ff08ba3b-5da2-4a99-a931-72c24d5a1835
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA077839
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- 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
- 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 | 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 |
|---|
| 68788-8399-2 | Albuterol Sulfate | 25 in 1 POUCH | SOLUTION | 25 | | 4 |
| 68788-8399-2 | Albuterol Sulfate | 3 mL in 1 AMPULE | SOLUTION | 3 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8399 | ALBUTEROL SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 2 package rows | 20250105_c90e80b2-882e-4c0c-bfac-d67eb1da724d.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 |
|---|
| 68788-8399-2 | 68788839902 | 25 AMPULE in 1 POUCH (68788-8399-2) / 3 mL in 1 AMPULE | 25 ampule | 2023-03-01 | No | No | Historical |