VENTOLINHFA
- Product NDC
- 21695-423
- 11-digit product format
- 216950423
- Labeler code
- 21695
- Product ID
- 21695-423_537a2996-2607-4ad1-9ce3-36dd8a3f5dfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- albuterol sulfate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Rebel Distributors Corp.
- Application
- NDA020983
- Marketing category
- NDA
- Marketing start
- 2006-06-09
- Marketing end
- 0000-00-00
- Substance
- ALBUTEROL SULFATE
- Active strength
- 108 ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 21695-423-08 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4d3a-48b1-e053-8cdaa90a720a | These highlights do not include all the information needed to use VENTOLIN HFA Inhalation Aerosol safely and effectively. See full prescribing information for VENTOLIN HFA Inhalation Aerosol. VENTOLIN ® HFA (albuterol sulfate) Inhalation Aerosol Initial U.S. Approval: 1981 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-423-08 | VENTOLINHFA HFA | 60 in 1 INHALER | AEROSOL, METERED | 60 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 801092 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin | PSN | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
| 801095 | Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 Actuations | PSN | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
| 801095 | NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin] | SBD | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
| 801092 | NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
| 801092 | albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose Inhaler | SY | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
| 801092 | albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler | SY | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
| 801092 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin | SY | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
| 801095 | NDA020983 60 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose Inhaler | SY | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
| 801095 | Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler | SY | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
| 801095 | Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 60 ACTUAT | SY | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
| 801095 | Ventolin HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler | SY | b1a801d6-9573-4997-9b4a-aec6db6459ed | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-423-08 | 21695042308 | 60 in 1 INHALER | Historical |