ALBUTEROL SULFATE
- Product NDC
- 65862-858
- 11-digit product format
- 658620858
- Labeler code
- 65862
- Product ID
- 65862-858_235055b3-2ceb-89e9-e063-6394a90aee19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ALBUTEROL SULFATE
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206224
- Marketing category
- ANDA
- Marketing start
- 2017-10-17
- 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
- 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 | .83 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 021SEF3731 |
| Rxcui | 630208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-858 | ALBUTEROL SULFATE SOLUTION [AUROBINDO PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 8 package rows | 20241001_eafa5b05-d692-48e7-a413-30f847547eb2.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 |
|---|
| 65862-858-03 | 65862085803 | 30 POUCH in 1 CARTON (65862-858-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 30 pouch | 2017-10-17 | 0000-00-00 | No | No | Current |
| 65862-858-25 | 65862085825 | 5 POUCH in 1 CARTON (65862-858-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 5 pouch | 2017-10-17 | 0000-00-00 | No | No | Current |
| 65862-858-30 | 65862085830 | 6 POUCH in 1 CARTON (65862-858-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 6 pouch | 2017-10-17 | 0000-00-00 | No | No | Current |
| 65862-858-60 | 65862085860 | 12 POUCH in 1 CARTON (65862-858-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 12 pouch | 2017-10-17 | 0000-00-00 | No | No | Current |