Albuterol Sulfate

Product NDC
70518-3560
Requested package NDC
70518-3560-0
11-digit product format
705183560
Labeler code
70518
Product ID
70518-3560_4f59960f-dfa0-4c66-e063-6294a90adfbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA207857
Marketing category
ANDA
Marketing start
2022-10-19
Substance
ALBUTEROL SULFATE
Active strength
.83 mg/mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage70518-356070518-3560-0DDiscontinued 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 · 10 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…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE.83 mg/mL

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
0f9bf2c8-55c0-4b4d-97de-d6c7220c3862Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
36390b75-5438-47d3-af60-732a654e9025Product name220220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3560-0Albuterol Sulfate12 in 1 CARTONSOLUTION126
70518-3560-0Albuterol Sulfate5 in 1 POUCHSOLUTION56
70518-3560-1Albuterol Sulfate5 in 1 CARTONSOLUTION56
70518-3560-1Albuterol Sulfate5 in 1 POUCHSOLUTION56

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
ndc (package): 70518-3560-0
ndc (product): 70518-3560
ndc11 (package): 70518356000
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 SolutionPSN0f9bf2c8-55c0-4b4d-97de-d6c7220c38626
630208albuterol 0.83 MG/ML Inhalation SolutionSCD0f9bf2c8-55c0-4b4d-97de-d6c7220c38626
630208albuterol 0.083 % Inhalation SolutionSY0f9bf2c8-55c0-4b4d-97de-d6c7220c38626
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY0f9bf2c8-55c0-4b4d-97de-d6c7220c38626
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY0f9bf2c8-55c0-4b4d-97de-d6c7220c38626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3560-07051835600012 POUCH in 1 CARTON (70518-3560-0) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL12 pouch2022-10-190000-00-00NoNoCurrent