Albuterol Sulfate
- Product NDC
- 87063-031
- 11-digit product format
- 870630031
- Labeler code
- 87063
- Product ID
- 87063-031_430d292d-dcb0-a30d-e063-6294a90ae859
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- ASCLEMED USA INC.
- 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 |
|---|---|
| ALBUTEROL SULFATE | 2.5 mg/3mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 021SEF3731 |
| Rxcui | 630208 |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87063-031-01 | Albuterol Sulfate | 30 in 1 CARTON | SOLUTION | 30 | 1 | |
| 87063-031-01 | Albuterol Sulfate | 1 in 1 POUCH | SOLUTION | 1 | 1 | |
| 87063-031-25 | Albuterol Sulfate | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 87063-031-25 | Albuterol Sulfate | 25 in 1 POUCH | SOLUTION | 25 | 1 | |
| 87063-031-30 | Albuterol Sulfate | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 87063-031-30 | Albuterol Sulfate | 30 in 1 POUCH | SOLUTION | 30 | 1 | |
| 87063-031-60 | Albuterol Sulfate | 30 in 1 POUCH | SOLUTION | 30 | 1 | |
| 87063-031-60 | Albuterol Sulfate | 2 in 1 CARTON | SOLUTION | 2 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 630208 | albuterol sulfate 0.083 % Inhalation Solution | PSN | 8ea40065-4f59-434f-9ea1-7ef006fde66e | 1 |
| 630208 | albuterol 0.83 MG/ML Inhalation Solution | SCD | 8ea40065-4f59-434f-9ea1-7ef006fde66e | 1 |
| 630208 | albuterol 0.083 % Inhalation Solution | SY | 8ea40065-4f59-434f-9ea1-7ef006fde66e | 1 |
| 630208 | albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution | SY | 8ea40065-4f59-434f-9ea1-7ef006fde66e | 1 |
| 630208 | albuterol 2.5 MG per 3 ML Inhalation Solution | SY | 8ea40065-4f59-434f-9ea1-7ef006fde66e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87063-031-01 | 87063003101 | 30 POUCH in 1 CARTON (87063-031-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 30 pouch | 2025-11-07 | No | No | Current |
| 87063-031-25 | 87063003125 | 1 POUCH in 1 CARTON (87063-031-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 1 pouch | 2025-11-07 | No | No | Current |
| 87063-031-30 | 87063003130 | 1 POUCH in 1 CARTON (87063-031-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 1 pouch | 2025-11-07 | No | No | Current |
| 87063-031-60 | 87063003160 | 2 POUCH in 1 CARTON (87063-031-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 2 pouch | 2025-11-07 | No | No | Current |