Albuterol Sulfate Inhalation Solution
- Product NDC
- 76204-010
- 11-digit product format
- 762040010
- Labeler code
- 76204
- Product ID
- 76204-010_4ffd498d-4575-dd61-e063-6394a90a95d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Ritedose Pharmaceuticals, LLC
- Application
- ANDA214531
- Marketing category
- ANDA
- Marketing start
- 2022-01-04
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Albuterol Sulfate Inhalation Solution
- Listing expiration
- 2027-12-31
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 |
|---|
| 76204-010-01 | Albuterol Sulfate Inhalation Solution | 30 in 1 CARTON | SOLUTION | 30 | | 10 |
| 76204-010-05 | Albuterol Sulfate Inhalation Solution | 3 mL in 1 VIAL | SOLUTION | 3 | | 10 |
| 76204-010-05 | Albuterol Sulfate Inhalation Solution | 5 in 1 POUCH | SOLUTION | 5 | | 10 |
| 76204-010-11 | Albuterol Sulfate Inhalation Solution | 3 mL in 1 VIAL | SOLUTION | 3 | | 10 |
| 76204-010-11 | Albuterol Sulfate Inhalation Solution | 1 in 1 POUCH | SOLUTION | 1 | | 10 |
| 76204-010-55 | Albuterol Sulfate Inhalation Solution | 25 in 1 CARTON | SOLUTION | 25 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76204-010 | ALBUTEROL SULFATE INHALATION SOLUTION (ALBUTEROL SULFATE) SOLUTION [RITEDOSE PHARMACEUTICALS, LLC] | 7 | Current NDC, Legacy NDC, 6 package rows | 20241219_d4c532be-1f41-60d3-e053-2995a90a98be.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76204-010-01 | 76204001001 | 30 POUCH in 1 CARTON (76204-010-01) / 1 VIAL in 1 POUCH (76204-010-11) / 3 mL in 1 VIAL | 30 pouch | 2022-01-04 | 0000-00-00 | No | No | Current |
| 76204-010-05 | 76204001005 | 3 mL in 1 VIAL | 3 ml | | | | | Historical |
| 76204-010-11 | 76204001011 | 3 mL in 1 VIAL | 3 ml | | | | | Historical |
| 76204-010-55 | 76204001055 | 25 POUCH in 1 CARTON (76204-010-55) / 5 VIAL in 1 POUCH (76204-010-05) / 3 mL in 1 VIAL | 25 pouch | 2022-01-04 | 0000-00-00 | No | No | Current |