Home NDC 68084-949-25 Albuterol Sulfate
Product NDC 68084-949
Requested package NDC 68084-949-25
11-digit product format 680840949
Labeler code 68084
Product ID 68084-949_1e7d3421-f562-17f5-e063-6294a90a9358
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol Sulfate
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA072637
Marketing category ANDA
Marketing start 2015-09-22
Substance ALBUTEROL SULFATE
Active strength 2 mg/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 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072637-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 A072637-002 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 88 observed 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 2026-10-15 13:18:30 2026-09 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 2 mg/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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197316 Internal RxNorm lookup 197318 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 68084-949-25 Albuterol Sulfate 30 in 1 BOX, UNIT-DOSE TABLET 30 5 68084-949-95 Albuterol Sulfate 1 in 1 BLISTER PACK TABLET 1 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-949 ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING] 5 Current NDC, Legacy NDC, 2 package rows 20240731_b0f73459-baeb-42a7-be48-2c3647d9b205.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68084-949-25 68084094925 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-949-25) / 1 TABLET in 1 BLISTER PACK (68084-949-95) 30 blister pack 2015-09-22 0000-00-00 No No Current