Albuterol Sulfate
- Product NDC
- 68788-8492
- 11-digit product format
- 687888492
- Labeler code
- 68788
- Product ID
- 68788-8492_84a25c79-3c24-4979-b295-2495b90eb295
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- albuterol sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA207857
- Marketing category
- ANDA
- Marketing start
- 2023-07-24
- 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 |
|---|
| 68788-8492-2 | Albuterol Sulfate | 5 in 1 CARTON | SOLUTION | 5 | | 3 |
| 68788-8492-2 | Albuterol Sulfate | 5 in 1 POUCH | SOLUTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8492 | ALBUTEROL SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 2 package rows | 20241017_5de6a189-a8b7-4b33-b162-add6b6e4b275.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 |
|---|
| 68788-8492-2 | 68788849202 | 5 POUCH in 1 CARTON (68788-8492-2) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL | 5 pouch | 2023-07-24 | No | No | Historical |