VENTOLIN
- Product NDC
- 50436-6050
- 11-digit product format
- 504366050
- Labeler code
- 50436
- Product ID
- 50436-6050_aa58d675-a818-482e-88be-f2f7236e09ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- albuterol sulfate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Unit Dose Services
- Application
- NDA020983
- Marketing category
- NDA
- Marketing start
- 2006-06-09
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- 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 |
| 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 |
|---|---|---|---|---|---|
| 50436-6050-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f752-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA. VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol Initial U.S. Approval: 1981 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-6050-0 | VENTOLIN HFA | 90 in 1 BOTTLE | AEROSOL, METERED | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-6050-0 | GM - Gram | 50436-6050 | 8a871c1e-3ef6-468d-927b-d94aa4aa8c51 | 1 | 2014-12-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ACTIVE INGREDIENT | 021SEF3731 | VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [UNIT DOSE SERVICES] | 2 | |
| ALBUTEROL | ACTIVE MOIETY | QF8SVZ843E | VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [UNIT DOSE SERVICES] | 2 | |
| NORFLURANE | INACTIVE INGREDIENT | DH9E53K1Y8 | VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [UNIT DOSE SERVICES] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-6050 | VENTOLIN HFA (ALBUTEROL SULFATE) AEROSOL, METERED [UNIT DOSE SERVICES] | 2 | Legacy NDC, 1 package rows | 20140401_e1821db2-8a50-40e1-8448-4e59eafd2612.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2123076 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for Ventolin | PSN | e1821db2-8a50-40e1-8448-4e59eafd2612 | 2 |
| 859088 | Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations | PSN | e1821db2-8a50-40e1-8448-4e59eafd2612 | 2 |
| 859088 | NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin] | SBD | e1821db2-8a50-40e1-8448-4e59eafd2612 | 2 |
| 2123076 | NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | e1821db2-8a50-40e1-8448-4e59eafd2612 | 2 |
| 2123076 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for Ventolin | SY | e1821db2-8a50-40e1-8448-4e59eafd2612 | 2 |
| 859088 | NDA020983 200 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose Inhaler | SY | e1821db2-8a50-40e1-8448-4e59eafd2612 | 2 |
| 859088 | Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUAT | SY | e1821db2-8a50-40e1-8448-4e59eafd2612 | 2 |
| 859088 | Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT | SY | e1821db2-8a50-40e1-8448-4e59eafd2612 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-6050-0 | 50436605000 | 90 in 1 BOTTLE | Historical |