Albuterol Sulfate

Product NDC
0591-3797
Requested package NDC
0591-3797-83
11-digit product format
005913797
Labeler code
0591
Product ID
0591-3797_bba96985-d9a9-4eed-9814-217cbbcbfc7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
INTRABRONCHIAL
Labeler
Actavis Pharma, Inc.
Application
ANDA077839
Marketing category
ANDA
Marketing start
2010-11-04
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
3 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0591-37970591-3797-83DDiscontinued by firm2026-08-03

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077839-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077839-001AN

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077839-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077839-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077839-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077839-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077839-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077839-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077839-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077839-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077839-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077839-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077839-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077839-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077839-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077839-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077839-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077839-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077839-001AN14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077839-001AN174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077839-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077839-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077839-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03A077839-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077839-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077839-001AN1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077839-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A077839-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077839-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077839-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077839-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077839-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077839-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077839-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077839-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077839-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077839-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077839-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077839-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077839-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077839-001AN1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077839-001AN1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3797-30ML - Milliliter0591-379718563f6b-aae2-45db-9cd8-32341d039fdf12012-07-24
0591-3797-60ML - Milliliter0591-3797658fe638-ab38-4e72-8b02-22b213b9225412012-07-24
0591-3797-83ML - Milliliter0591-379757224a91-d894-4287-b957-573c853b8c5e12012-07-24

DailyMed Socrata Ingredients#

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATEAmerican Health Packaging4aec7f59-b429-4b0e-a779-8df1dd8f80d72026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATERitedose Pharmaceuticals, LLCb72742df-1a6b-4483-aff3-3e79db5e015d2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATECardinal Health 107, LLCd2132c1c-0f90-4c6f-afc0-f3814b6a7e5c2026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATECardinal Health 107, LLC6ec88f64-66a2-4ca9-9913-c192fc33f88b2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.c90e80b2-882e-4c0c-bfac-d67eb1da724d2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATEMylan Pharmaceuticals Inc.5329614f-ae0b-4854-bb6f-ea0b7dae87c02026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals, Inc.2c3f975c-dbd8-0362-e063-6394a90a16dd2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATEA-S Medication Solutions19867b61-77a2-46f1-97c7-7fadfec5882b2024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATEMedical Purchasing Solutions, LLC6a4b4b95-d1d3-9051-e053-2a91aa0a52e82023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSN8ee98719-c248-4373-e053-2995a90ae6261
630208albuterol sulfate 0.083 % Inhalation SolutionPSN96123aee-a61b-7c57-e053-2995a90a5aa61
630208albuterol 0.83 MG/ML Inhalation SolutionSCD8ee98719-c248-4373-e053-2995a90ae6261
630208albuterol 0.83 MG/ML Inhalation SolutionSCD96123aee-a61b-7c57-e053-2995a90a5aa61
630208albuterol 0.083 % Inhalation SolutionSY8ee98719-c248-4373-e053-2995a90ae6261
630208albuterol 0.083 % Inhalation SolutionSY96123aee-a61b-7c57-e053-2995a90a5aa61
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY8ee98719-c248-4373-e053-2995a90ae6261
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY96123aee-a61b-7c57-e053-2995a90a5aa61
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY8ee98719-c248-4373-e053-2995a90ae6261
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY96123aee-a61b-7c57-e053-2995a90a5aa61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3797-830059137978325 VIAL in 1 CARTON (0591-3797-83) > 3 mL in 1 VIAL25 vial2010-11-040000-00-00NoNoCurrent