Home NDC 66689-100 Albuterol Sulfate
Product NDC 66689-100
11-digit product format 666890100
Labeler code 66689
Product ID 66689-100_737932ca-a391-48c3-96c5-14de8ae1000e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol
Dosage form SYRUP
Route ORAL
Labeler VistaPharm, Inc.
Application ANDA077788
Marketing category ANDA
Marketing start 2016-09-07
Marketing end 0000-00-00
Substance ALBUTEROL SULFATE
Active strength 2 mg/5mL
Pharmacologic classes Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66689-100-08 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66689-100-08 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66689-100-08 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66689-100-08 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66689-100-08 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66689-100-08 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66689-100-08 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66689-100-08 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66689-100-08 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66689-100-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66689-100-08 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66689-100-08 557ba5c1ecfa…9c80585c8c6e…
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 A077788-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077788-001 AA
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 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL 2007-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL 2007-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL 2007-06-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL 2007-06-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL 2007-06-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL 2007-06-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL 2007-06-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL 2007-06-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077788-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL AA 2007-06-26 cb3db0bc1861…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66689-100-08 66689010008 12 BOTTLE in 1 CASE (66689-100-08) > 473 mL in 1 BOTTLE (66689-100-16) 12 bottle 2016-09-07 0000-00-00 No No Current