Home NDC 53489-177 albuterol sulfate
Product NDC 53489-177
11-digit product format 534890177
Labeler code 53489
Product ID 53489-177_4d289f6d-634d-2125-e063-6394a90aa25d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name albuterol sulfate
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA072637
Marketing category ANDA
Marketing start 1989-12-05
Substance ALBUTEROL SULFATE
Active strength 4 mg/1
Pharmacologic classes Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 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 · 82 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 2026-02-19 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…2019-12-13 00:20 UTC 2019-12 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072637-001 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 1989-12-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A072637-002 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 1989-12-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base albuterol sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALBUTEROL SULFATE 4 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 53489-177-01 albuterol sulfate 100 in 1 BOTTLE TABLET 100 7 53489-177-02 albuterol sulfate 50 in 1 BOTTLE TABLET 50 7 53489-177-03 albuterol sulfate 250 in 1 BOTTLE TABLET 250 7 53489-177-05 albuterol sulfate 500 in 1 BOTTLE TABLET 500 7 53489-177-10 albuterol sulfate 1000 in 1 BOTTLE TABLET 1000 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded albuterol sulfate ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 ALBUTEROL SULFATE ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 ALBUTEROL ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 albuterol ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK ALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 ALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 starch, corn INACTIVE INGREDIENT O8232NY3SJ ALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 albuterol sulfate ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING] 1 albuterol ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING] 1 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING] 1 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING] 1 starch, corn INACTIVE INGREDIENT O8232NY3SJ ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53489-177 ALBUTEROL SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 Current NDC, Legacy NDC, 5 package rows 20190207_87b8cd3c-2849-4b50-b63e-9ea379165c07.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 53489-177-01 53489017701 100 TABLET in 1 BOTTLE (53489-177-01) 100 tablet 1989-12-05 0000-00-00 No No Current 53489-177-02 53489017702 50 TABLET in 1 BOTTLE (53489-177-02) 50 tablet 1989-12-05 0000-00-00 No No Current 53489-177-03 53489017703 250 TABLET in 1 BOTTLE (53489-177-03) 250 tablet 1989-12-05 0000-00-00 No No Current 53489-177-05 53489017705 500 TABLET in 1 BOTTLE (53489-177-05) 500 tablet 1989-12-05 0000-00-00 No No Current 53489-177-10 53489017710 1000 TABLET in 1 BOTTLE (53489-177-10) 1000 tablet 1989-12-05 0000-00-00 No No Current