Albuterol Sulfate

Product NDC
68071-4754
Requested package NDC
68071-4754-2
11-digit product format
680714754
Labeler code
68071
Product ID
68071-4754_2d7cdf76-7c87-8de1-e063-6394a90a0c2c
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
Substance
ALBUTEROL SULFATE
Active strength
2.5 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-475468071-4754-2IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-475468071-4754-2IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-475468071-4754-2IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2.5 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
021SEF3731Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
630208Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
813d49be-3651-6759-e053-2991aa0a6a9fAvailable on FDA.report

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
68071-4754-2Albuterol Sulfate3 mL in 1 VIAL, SINGLE-DOSESOLUTION35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4754ALBUTEROL SULFATE SOLUTION [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20250209_813d49be-3651-6759-e053-2991aa0a6a9f.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 · 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
ndc (package): 68071-4754-2
ndc (product): 68071-4754
ndc11 (package): 68071475402
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSN813d49be-3651-6759-e053-2991aa0a6a9f5
630208albuterol 0.83 MG/ML Inhalation SolutionSCD813d49be-3651-6759-e053-2991aa0a6a9f5
630208albuterol 0.083 % Inhalation SolutionSY813d49be-3651-6759-e053-2991aa0a6a9f5
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY813d49be-3651-6759-e053-2991aa0a6a9f5
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY813d49be-3651-6759-e053-2991aa0a6a9f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4754-2680714754023 mL in 1 VIAL, SINGLE-DOSE (68071-4754-2) 3 ml2019-02-060000-00-00NoNoCurrent