Home NDC 81894-104 ALBUTEROL SULFATE
Product NDC 81894-104
11-digit product format 818940104
Labeler code 81894
Product ID 81894-104_5b80e7da-01a7-6709-e063-6294a90adb9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ALBUTEROL SULFATE
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206224-001 ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION / INHALATION AN 2017-10-17 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALBUTEROL SULFATE .83 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81894-104 ALBUTEROL SULFATE SOLUTION [LUOXIN AUROVITAS PHARMA (CHENGDU) CO., LTD.] 3 Current NDC, 8 package rows 20241001_1810ff8e-d505-bf9c-e063-6394a90a6540.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81894-104-02 81894010402 30 POUCH in 1 CARTON (81894-104-02) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 30 pouch 2017-10-17 No No Current 81894-104-25 81894010425 5 POUCH in 1 CARTON (81894-104-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 5 pouch 2017-10-17 No No Current 81894-104-30 81894010430 6 POUCH in 1 CARTON (81894-104-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 6 pouch 2017-10-17 No No Current 81894-104-60 81894010460 12 POUCH in 1 CARTON (81894-104-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 12 pouch 2017-10-17 No No Current