ALBUTEROL SULFATE
- Product NDC
- 70752-102
- 11-digit product format
- 707520102
- Labeler code
- 70752
- Product ID
- 70752-102_f8b35fdc-741f-4ebd-91d5-a55a7ef8e261
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ALBUTEROL SULFATE
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- QUAGEN PHARMACEUTICALS LLC
- Application
- ANDA212197
- Marketing category
- ANDA
- Marketing start
- 2019-09-06
- Substance
- ALBUTEROL SULFATE
- Active strength
- 2 mg/5mL
- 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 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 021SEF3731 |
| Rxcui | 755497 |
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 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 36390b75-5438-47d3-af60-732a654e9025 | Product name | 2 | 20220110 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| 387afa72-0c5a-0d6b-ee2c-60c3506659e8 | Product name | 6 | 20210518 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 1b8ea3ec-88bd-98ea-c961-00ae340b5b14 | Product name | 2 | 20200220 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 3aa5a017-61e9-0c89-adef-13e7964d22f0 | Product name | 3 | 20171208 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
|---|---|---|---|---|---|
| 70752-102-12 | 2023-02-15 | C162847 | 48780-1 | f386c649-e851-0266-e053-dadaa90a7c1a | Albuterol Sulfate Syrup, 2 mg/5 mL Rx only |
| 70752-102-12 | 2023-01-30 | C162847 | 48780-1 | f386c649-e851-0266-e053-dadaa90a7c1a | Albuterol Sulfate Syrup, 2 mg/5 mL Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70752-102-12 | ALBUTEROL SULFATE | 473 mL in 1 BOTTLE | SYRUP | 473 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70752-102-12 | ML - Milliliter | 70752-102 | 1032f295-477f-41cb-a978-d772cfbbfa81 | 1 | 2019-11-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 755497 | albuterol sulfate 2 MG in 5 mL Oral Solution | PSN | 45e07bdd-78f9-4055-9de3-646e67de7eaf | 101 |
| 755497 | albuterol 0.4 MG/ML Oral Solution | SCD | 45e07bdd-78f9-4055-9de3-646e67de7eaf | 101 |
| 755497 | albuterol (as albuterol sulfate) 2 MG per 5 ML Syrup | SY | 45e07bdd-78f9-4055-9de3-646e67de7eaf | 101 |
| 755497 | albuterol 2 MG per 5 ML Syrup | SY | 45e07bdd-78f9-4055-9de3-646e67de7eaf | 101 |
| 755497 | albuterol sulfate 2 MG in 5 mL Oral Solution | PSN | 378461f2-7271-44a3-9da3-b39970b65d3a | 100 |
| 755497 | albuterol 0.4 MG/ML Oral Solution | SCD | 378461f2-7271-44a3-9da3-b39970b65d3a | 100 |
| 755497 | albuterol (as albuterol sulfate) 2 MG per 5 ML Syrup | SY | 378461f2-7271-44a3-9da3-b39970b65d3a | 100 |
| 755497 | albuterol 2 MG per 5 ML Syrup | SY | 378461f2-7271-44a3-9da3-b39970b65d3a | 100 |
| 755497 | albuterol sulfate 2 MG in 5 mL Oral Solution | PSN | 4aafc2dd-744d-4726-828f-70355aee6f70 | 6 |
| 755497 | albuterol 0.4 MG/ML Oral Solution | SCD | 4aafc2dd-744d-4726-828f-70355aee6f70 | 6 |
| 755497 | albuterol (as albuterol sulfate) 2 MG per 5 ML Syrup | SY | 4aafc2dd-744d-4726-828f-70355aee6f70 | 6 |
| 755497 | albuterol 2 MG per 5 ML Syrup | SY | 4aafc2dd-744d-4726-828f-70355aee6f70 | 6 |
| 755497 | albuterol sulfate 2 MG in 5 mL Oral Solution | PSN | 99a490cc-e41d-436b-9cf3-8facb7ac714f | 3 |
| 755497 | albuterol 0.4 MG/ML Oral Solution | SCD | 99a490cc-e41d-436b-9cf3-8facb7ac714f | 3 |
| 755497 | albuterol (as albuterol sulfate) 2 MG per 5 ML Syrup | SY | 99a490cc-e41d-436b-9cf3-8facb7ac714f | 3 |
| 755497 | albuterol 2 MG per 5 ML Syrup | SY | 99a490cc-e41d-436b-9cf3-8facb7ac714f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70752-102-12 | 70752010212 | 473 mL in 1 BOTTLE (70752-102-12) | 473 ml | 2019-09-06 | 0000-00-00 | No | No | Current |