Home NDC 68788-4041 Albuterol Sulfate
Product NDC 68788-4041
11-digit product format 687884041
Labeler code 68788
Product ID 68788-4041_081b7bbb-6692-4512-b135-863b73bf30a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol Sulfate
Dosage form INHALANT
Route RESPIRATORY (INHALATION)
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA212447
Marketing category ANDA
Marketing start 2025-10-13
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212447-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212447-001 AB2
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212447-001 ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED / INHALATION AB2 2024-05-21 a50c72e98297…
Observed Orange Book normalized TE history# 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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 021SEF3731 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2123072 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-4041-2 Albuterol Sulfate 200 in 1 INHALER INHALANT 200 1 68788-4041-2 Albuterol Sulfate 1 in 1 CARTON INHALANT 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-4041-2 68788404102 1 INHALER in 1 CARTON (68788-4041-2) / 200 INHALANT in 1 INHALER 1 inhaler 2025-10-13 No No Current