Home NDC 59651-333 Albuterol
Product NDC 59651-333
11-digit product format 596510333
Labeler code 59651
Product ID 59651-333_f89dffb1-5c4b-48aa-90b4-74043fc9b690
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA213657
Marketing category ANDA
Marketing start 2020-05-14
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 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 A213657-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 A213657-002 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14
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 2 · 74 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 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213657-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 2020-05-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213657-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 2020-05-14 87673890dc5c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2020-11-12 02:37 UTC 2020-11 A213657-001 AB 1 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A213657-002 AB 1 c0c555d07b60…
Additional Listing Data#
Finished product Yes
Brand name base Albuterol
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 59651-333-01 Albuterol 100 in 1 BOTTLE TABLET 100 3 59651-333-05 Albuterol 500 in 1 BOTTLE TABLET 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-333 ALBUTEROL TABLET [AUROBINDO PHARMA LIMITED] 3 Current NDC, Legacy NDC, 2 package rows 20230111_ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6.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 · 1 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 59651-333-01 59651033301 100 TABLET in 1 BOTTLE (59651-333-01) 100 tablet 2020-05-14 0000-00-00 No No Current 59651-333-05 59651033305 500 TABLET in 1 BOTTLE (59651-333-05) 500 tablet 2020-05-14 0000-00-00 No No Current