Albuterol Sulfate

Product NDC
68071-2656
11-digit product format
680712656
Labeler code
68071
Product ID
68071-2656_da44f13e-99d6-6d7a-e053-2a95a90aae65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207857
Marketing category
ANDA
Marketing start
2021-06-11
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
1 mg/mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct68071-2656IInactivated by FDA2026-08-03
excluded packagepackage68071-265668071-2656-2IInactivated by FDA2026-08-03

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2656-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2656-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2656-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2656-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2656-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2656-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2656-2UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2656-2UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2656-2UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A207857-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207857-001AN

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 UTC2026-02A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-213f01610625f2…
2019-09-15 20:21 UTC2019-09A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207857-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2017-07-21cb3db0bc1861…

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 UTC2026-02A207857-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207857-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207857-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207857-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207857-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207857-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207857-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207857-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207857-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207857-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207857-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207857-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207857-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207857-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207857-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207857-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207857-001AN14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207857-001AN174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207857-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207857-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207857-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03A207857-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207857-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207857-001AN1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207857-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A207857-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207857-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207857-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207857-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207857-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207857-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207857-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207857-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207857-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207857-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207857-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207857-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207857-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207857-001AN1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207857-001AN1cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2656-2Albuterol Sulfate5 in 1 POUCHSOLUTION51
68071-2656-2Albuterol Sulfate5 in 1 CARTONSOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2656ALBUTEROL SULFATE SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220316_da44f13e-99d5-6d7a-e053-2a95a90aae65.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATEREMEDYREPACK INC.0f9bf2c8-55c0-4b4d-97de-d6c7220c38622026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207857
application number: ANDA207857
Albuterol SulfateALBUTEROL SULFATESun Pharmaceutical Industries, Inc.bb538b7d-e390-419a-9404-a57c1db4a4472026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207857
application number: ANDA207857
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.5de6a189-a8b7-4b33-b162-add6b6e4b2752026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207857
application number: ANDA207857
Albuterol SulfateALBUTEROL SULFATEProficient Rx LPa6545fbe-b0a6-41ae-8bb6-91af38410f562025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207857
application number: ANDA207857

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSNda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 0.83 MG/ML Inhalation SolutionSCDda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 0.083 % Inhalation SolutionSYda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYda44f13e-99d5-6d7a-e053-2a95a90aae651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2656-2680712656025 POUCH in 1 CARTON (68071-2656-2) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL5 pouch2022-03-150000-00-00NoNoCurrent