Albuterol Sulfate
- Product NDC
- 0472-0825
- 11-digit product format
- 004720825
- Labeler code
- 0472
- Product ID
- 0472-0825_d129e8b6-6957-7b79-e053-2995a90a94e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA074454
- Marketing category
- ANDA
- Marketing start
- 2016-02-19
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- 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 |
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0472-0825-16 | ML - Milliliter | 0472-0825 | 2a87c4e7-37de-4b28-b5ab-0fc7cfd3f245 | 1 | 2016-03-04 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 755497 | albuterol sulfate 2 MG in 5 mL Oral Solution | PSN | 6ac5a71c-0652-1400-e053-2a91aa0a3e83 | 3 |
| 755497 | albuterol 0.4 MG/ML Oral Solution | SCD | 6ac5a71c-0652-1400-e053-2a91aa0a3e83 | 3 |
| 755497 | albuterol (as albuterol sulfate) 2 MG per 5 ML Syrup | SY | 6ac5a71c-0652-1400-e053-2a91aa0a3e83 | 3 |
| 755497 | albuterol 2 MG per 5 ML Syrup | SY | 6ac5a71c-0652-1400-e053-2a91aa0a3e83 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0472-0825-04 | 00472082504 | 118 mL in 1 BOTTLE (0472-0825-04) | 118 ml | 2016-02-19 | 0000-00-00 | No | No | Current |
| 0472-0825-16 | 00472082516 | 473 mL in 1 BOTTLE (0472-0825-16) | 473 ml | 2016-02-19 | 0000-00-00 | No | No | Current |