Albuterol Sulfate
- Product NDC
- 68071-4543
- 11-digit product format
- 680714543
- Labeler code
- 68071
- Product ID
- 68071-4543_2b3707fa-ceec-d6c9-e063-6294a90a1cc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- NuCare Pharmaceuticals,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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4543-6 | 2024-06-10 | C162847 | 48780-1 | ba0f9c33-595e-a910-e053-dadaa90a0b85 | Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml |
| 68071-4543-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-595e-a910-e053-dadaa90a0b85 | Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml |
| 68071-4543-6 | 2021-02-19 | C162847 | 48780-1 | ba0f9c33-595e-a910-e053-dadaa90a0b85 | Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml |
| 68071-4543-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-595e-a910-e053-dadaa90a0b85 | Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4543-6 | Albuterol Sulfate | 3 mL in 1 CONTAINER | SOLUTION | 3 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4543 | ALBUTEROL SULFATE SOLUTION [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250212_749992b4-69e0-0cc8-e053-2991aa0aeb25.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 630208 | albuterol sulfate 0.083 % Inhalation Solution | PSN | 749992b4-69e0-0cc8-e053-2991aa0aeb25 | 6 |
| 630208 | albuterol 0.83 MG/ML Inhalation Solution | SCD | 749992b4-69e0-0cc8-e053-2991aa0aeb25 | 6 |
| 630208 | albuterol 0.083 % Inhalation Solution | SY | 749992b4-69e0-0cc8-e053-2991aa0aeb25 | 6 |
| 630208 | albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution | SY | 749992b4-69e0-0cc8-e053-2991aa0aeb25 | 6 |
| 630208 | albuterol 2.5 MG per 3 ML Inhalation Solution | SY | 749992b4-69e0-0cc8-e053-2991aa0aeb25 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-4543-6 | 68071454306 | 3 mL in 1 CONTAINER (68071-4543-6) | 3 ml | 2018-08-29 | 0000-00-00 | No | No | Current |