Albuterol Sulfate
- Product NDC
- 0054-0742
- 11-digit product format
- 000540742
- Labeler code
- 0054
- Product ID
- 0054-0742_07a1b9ad-58cb-4c21-b8df-6854da990f85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA207085
- Marketing category
- ANDA
- Marketing start
- 2021-11-30
- Substance
- ALBUTEROL SULFATE
- Active strength
- 90 ug/1
- 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 | 90 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 021SEF3731 |
| Rxcui | 2123111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0742-87 | Albuterol Sulfate | 200 in 1 CANISTER | AEROSOL, METERED | 200 | | 2 |
| 0054-0742-87 | Albuterol Sulfate | 1 in 1 CARTON | AEROSOL, METERED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0742 | ALBUTEROL SULFATE AEROSOL, METERED [HIKMA PHARMACEUTICALS USA INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230111_6c64ab5d-f8a2-440a-a929-cb8188d0e8b4.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | PSN | e31d8d13-ac19-4738-97d4-d7790ce2e8e3 | 4 |
| 2123111 | NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | e31d8d13-ac19-4738-97d4-d7790ce2e8e3 | 4 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | SY | e31d8d13-ac19-4738-97d4-d7790ce2e8e3 | 4 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | PSN | 1f0bf143-66d4-4a39-b2d1-a5c460ffdcf9 | 2 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | PSN | 6c64ab5d-f8a2-440a-a929-cb8188d0e8b4 | 2 |
| 2123111 | NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 1f0bf143-66d4-4a39-b2d1-a5c460ffdcf9 | 2 |
| 2123111 | NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 6c64ab5d-f8a2-440a-a929-cb8188d0e8b4 | 2 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | SY | 1f0bf143-66d4-4a39-b2d1-a5c460ffdcf9 | 2 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | SY | 6c64ab5d-f8a2-440a-a929-cb8188d0e8b4 | 2 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | PSN | 53eecdef-a7ff-4ca3-a313-d4b9c29c898d | 1 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | PSN | 87ff8be7-3a49-44bd-92de-eb8db24af95b | 1 |
| 2123111 | NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 53eecdef-a7ff-4ca3-a313-d4b9c29c898d | 1 |
| 2123111 | NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 87ff8be7-3a49-44bd-92de-eb8db24af95b | 1 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | SY | 53eecdef-a7ff-4ca3-a313-d4b9c29c898d | 1 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | SY | 87ff8be7-3a49-44bd-92de-eb8db24af95b | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0742-87 | 00054074287 | 1 CANISTER in 1 CARTON (0054-0742-87) / 200 AEROSOL, METERED in 1 CANISTER | 1 canister | 2021-11-30 | 0000-00-00 | No | No | Current |