Albuterol Sulfate

Product NDC
66267-746
11-digit product format
662670746
Labeler code
66267
Product ID
66267-746_9cbe59db-9255-3a78-e053-2995a90aa4e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Nucare Pharmaceuticals, Inc.
Application
ANDA074880
Marketing category
ANDA
Marketing start
1997-09-17
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66267-746DDiscontinued by firm2026-08-03
excluded packagepackage66267-74666267-746-06DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-746-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-746-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-746-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-746-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-746-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-746-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-746-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-746-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-746-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-746-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66267-746-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-746-06557ba5c1ecfa…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
A074880-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074880-001AN

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 UTC2026-02A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-173f01610625f2…
2019-09-15 20:21 UTC2019-09A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074880-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONANRS1997-09-17cb3db0bc1861…

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 UTC2026-02A074880-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074880-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074880-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074880-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074880-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074880-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074880-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074880-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074880-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074880-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074880-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074880-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074880-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074880-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074880-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074880-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074880-001AN14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074880-001AN174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074880-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074880-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074880-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03A074880-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074880-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074880-001AN1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074880-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A074880-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074880-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074880-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074880-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074880-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074880-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074880-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074880-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074880-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074880-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074880-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074880-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074880-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074880-001AN1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074880-001AN1cb3db0bc1861…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATERising Pharma Holdings, Inc.32377c09-da6d-331c-e063-6294a90a7a462026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
Albuterol SulfateALBUTEROL SULFATESportpharm LLCa33e20e0-3936-450d-a9d9-3ff51c6f26c52026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
Albuterol SulfateALBUTEROL SULFATENephron Pharmaceuticals Corporation574824f3-51cc-4b94-9c10-e3204d8b19f82025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
Albuterol SulfateALBUTEROL SULFATEASCLEMED USA INC.8ea40065-4f59-434f-9ea1-7ef006fde66e2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.056e145b-87aa-4009-a7ab-2ac0bd086eb02025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.813d49be-3651-6759-e053-2991aa0a6a9f2025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.749992b4-69e0-0cc8-e053-2991aa0aeb252025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirst9d4ef83f-8ca0-811e-e053-2995a90a6d0d2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
Albuterol SulfateALBUTEROL SULFATEChartwell RX, LLC922bf33b-4d55-4c35-9f68-72efbb17c14f2024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
Albuterol SulfateALBUTEROL SULFATEA-S Medication Solutions8f52f15f-3fb7-4b00-a19f-8721c5ac55db2023-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
Albuterol SulfateALBUTEROL SULFATEProficient Rx LPd3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d2020-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074880
application number: ANDA074880

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66267-746-06662670746066 VIAL, SINGLE-DOSE in 1 BOTTLE (66267-746-06) > 3 mL in 1 VIAL, SINGLE-DOSE2016-09-010000-00-00NoNoCurrent