Albuterol Sulfate
- Product NDC
- 63187-204
- 11-digit product format
- 631870204
- Labeler code
- 63187
- Product ID
- 63187-204_621471a7-e06e-4d18-be4b-aca66c225a39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Proficient Rx LP
- Application
- ANDA074880
- Marketing category
- ANDA
- Marketing start
- 1997-09-17
- 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 |
|---|
| 63187-204-25 | Albuterol Sulfate | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
| 63187-204-25 | Albuterol Sulfate | 25 in 1 POUCH | SOLUTION | 25 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-204 | ALBUTEROL SULFATE SOLUTION [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 2 package rows | 20221129_d3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b.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 |
|---|
| 63187-204-25 | 63187020425 | 1 POUCH in 1 CARTON (63187-204-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 1 pouch | 2018-11-01 | 0000-00-00 | No | No | Current |