Albuterol Sulfate
- Product NDC
- 0591-3797
- 11-digit product format
- 005913797
- Labeler code
- 0591
- Product ID
- 0591-3797_bba96985-d9a9-4eed-9814-217cbbcbfc7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- INTRABRONCHIAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA077839
- Marketing category
- ANDA
- Marketing start
- 2010-11-04
- Marketing end
- 0000-00-00
- Substance
- ALBUTEROL SULFATE
- Active strength
- 3 mg/3mL
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 26005090-31a1-441d-920b-db3101a55d53 | Product name | 3 | 20250221 |
| 1c39b897-7219-42a1-9f3a-ec86cfd7b04b | Product name | 3 | 20250218 |
| 0a278166-c8aa-41b6-b4a5-6ac332bde76a | Product name | 1 | 20230718 |
| c76bcd0f-25eb-471e-b970-1956c95c26c5 | Product name | 1 | 20230425 |
| 36390b75-5438-47d3-af60-732a654e9025 | Product name | 2 | 20220110 |
| 387afa72-0c5a-0d6b-ee2c-60c3506659e8 | Product name | 6 | 20210518 |
| 1b8ea3ec-88bd-98ea-c961-00ae340b5b14 | Product name | 2 | 20200220 |
| 3aa5a017-61e9-0c89-adef-13e7964d22f0 | Product name | 3 | 20171208 |
| c3c27a99-b8bc-4955-841c-26555f58ee7e | Product name | 1 | 20150421 |
| bc98cf6f-a973-7162-5e30-0e7dd8c56bc3 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3797-30 | ML - Milliliter | 0591-3797 | 18563f6b-aae2-45db-9cd8-32341d039fdf | 1 | 2012-07-24 |
| 0591-3797-60 | ML - Milliliter | 0591-3797 | 658fe638-ab38-4e72-8b02-22b213b92254 | 1 | 2012-07-24 |
| 0591-3797-83 | ML - Milliliter | 0591-3797 | 57224a91-d894-4287-b957-573c853b8c5e | 1 | 2012-07-24 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 630208 | albuterol sulfate 0.083 % Inhalation Solution | PSN | 8ee98719-c248-4373-e053-2995a90ae626 | 1 |
| 630208 | albuterol sulfate 0.083 % Inhalation Solution | PSN | 96123aee-a61b-7c57-e053-2995a90a5aa6 | 1 |
| 630208 | albuterol 0.83 MG/ML Inhalation Solution | SCD | 8ee98719-c248-4373-e053-2995a90ae626 | 1 |
| 630208 | albuterol 0.83 MG/ML Inhalation Solution | SCD | 96123aee-a61b-7c57-e053-2995a90a5aa6 | 1 |
| 630208 | albuterol 0.083 % Inhalation Solution | SY | 8ee98719-c248-4373-e053-2995a90ae626 | 1 |
| 630208 | albuterol 0.083 % Inhalation Solution | SY | 96123aee-a61b-7c57-e053-2995a90a5aa6 | 1 |
| 630208 | albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution | SY | 8ee98719-c248-4373-e053-2995a90ae626 | 1 |
| 630208 | albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution | SY | 96123aee-a61b-7c57-e053-2995a90a5aa6 | 1 |
| 630208 | albuterol 2.5 MG per 3 ML Inhalation Solution | SY | 8ee98719-c248-4373-e053-2995a90ae626 | 1 |
| 630208 | albuterol 2.5 MG per 3 ML Inhalation Solution | SY | 96123aee-a61b-7c57-e053-2995a90a5aa6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-3797-30 | 00591379730 | 30 VIAL in 1 CARTON (0591-3797-30) > 3 mL in 1 VIAL | 30 vial | 2010-11-04 | 0000-00-00 | No | No | Current |
| 0591-3797-60 | 00591379760 | 60 VIAL in 1 CARTON (0591-3797-60) > 3 mL in 1 VIAL | 60 vial | 2010-11-04 | 0000-00-00 | No | No | Current |
| 0591-3797-83 | 00591379783 | 25 VIAL in 1 CARTON (0591-3797-83) > 3 mL in 1 VIAL | 25 vial | 2010-11-04 | 0000-00-00 | No | No | Current |