Home NDC 65862-858 ALBUTEROL SULFATE
Product NDC 65862-858
11-digit product format 658620858
Labeler code 65862
Product ID 65862-858_235055b3-2ceb-89e9-e063-6394a90aee19
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ALBUTEROL SULFATE
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Aurobindo Pharma Limited
Application ANDA206224
Marketing category ANDA
Marketing start 2017-10-17
Substance ALBUTEROL SULFATE
Active strength .83 mg/mL
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 A206224-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206224-001 AN
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 · 41 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 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 .83 mg/mL
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 630208 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-858 ALBUTEROL SULFATE SOLUTION [AUROBINDO PHARMA LIMITED] 7 Current NDC, Legacy NDC, 8 package rows 20241001_eafa5b05-d692-48e7-a413-30f847547eb2.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 65862-858-03 65862085803 30 POUCH in 1 CARTON (65862-858-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 30 pouch 2017-10-17 0000-00-00 No No Current 65862-858-25 65862085825 5 POUCH in 1 CARTON (65862-858-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 5 pouch 2017-10-17 0000-00-00 No No Current 65862-858-30 65862085830 6 POUCH in 1 CARTON (65862-858-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 6 pouch 2017-10-17 0000-00-00 No No Current 65862-858-60 65862085860 12 POUCH in 1 CARTON (65862-858-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 12 pouch 2017-10-17 0000-00-00 No No Current