Home NDC 59651-183 ALBUTEROL SULFATE
Product NDC 59651-183
11-digit product format 596510183
Labeler code 59651
Product ID 59651-183_1e853c87-b534-65d2-e063-6394a90a7923
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ALBUTEROL SULFATE
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Aurobindo Pharma Limited
Application ANDA211888
Marketing category ANDA
Marketing start 2020-04-20
Substance ALBUTEROL SULFATE
Active strength .63 mg/3mL
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 A211888-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 A211888-002 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20
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 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 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2020-04-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2020-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION 2020-04-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION 2020-04-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION 2020-04-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION 2020-04-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION 2020-04-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION 2020-04-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION 2020-04-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION 2020-04-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION 2020-04-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION 2020-04-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION 2020-04-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION 2020-04-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION 2020-04-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION 2020-04-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211888-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION 2020-04-20 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211888-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION 2020-04-20 87673890dc5c…
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 .63 mg/3mL
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 351136 Internal RxNorm lookup 351137 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 59651-183-25 ALBUTEROL SULFATE 5 in 1 CARTON SOLUTION 5 8 59651-183-25 ALBUTEROL SULFATE 5 in 1 POUCH SOLUTION 5 8 59651-183-30 ALBUTEROL SULFATE 5 in 1 POUCH SOLUTION 5 8 59651-183-30 ALBUTEROL SULFATE 6 in 1 CARTON SOLUTION 6 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-183 ALBUTEROL SULFATE SOLUTION [AUROBINDO PHARMA LIMITED] 8 Current NDC, Legacy NDC, 4 package rows 20240801_78e6bee2-7113-46cf-8c97-dc61b0f7b94f.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 · 2 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 59651-183-25 59651018325 5 POUCH in 1 CARTON (59651-183-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL 5 pouch 2020-04-20 0000-00-00 No No Current 59651-183-30 59651018330 6 POUCH in 1 CARTON (59651-183-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL 6 pouch 2024-07-29 No No Current