Albuterol Sulfate

Product NDC
21695-350
11-digit product format
216950350
Labeler code
21695
Product ID
21695-350_071e819b-43cd-48f7-b63e-c891936dcfc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SYRUP
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074749
Marketing category
ANDA
Marketing start
1998-01-30
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
2 mg/5mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct21695-350IInactivated by FDA2026-08-03
excluded packagepackage21695-35021695-350-16IInactivated 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 · 44 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 packagepackage21695-350-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-350-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-350-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-350-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-350-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-350-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-350-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-350-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-350-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-350-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-350-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-350-16557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-350-168af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-350-16834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-350-161332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-350-16fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-350-1686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-350-16bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-350-168dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-350-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-350-169bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-350-16110d247fa046…a55b01930146…

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
A074749-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-30

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 UTC2026-02A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORAL1998-01-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-303f01610625f2…
2019-09-15 20:21 UTC2019-09A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074749-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA1998-01-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074749-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074749-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074749-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074749-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074749-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074749-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074749-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A074749-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074749-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074749-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074749-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A074749-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074749-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074749-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074749-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074749-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074749-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074749-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074749-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074749-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074749-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074749-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074749-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074749-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074749-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074749-001AA1cb3db0bc1861…

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
36390b75-5438-47d3-af60-732a654e9025Product name220220110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-350-162019-09-24C16284748780-1934fe258-4b15-48b1-e053-8cdaa90a720aAlbuterol Sulfate Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-350-16Albuterol Sulfate473 mL in 1 BOTTLESYRUP4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-350-16ML - Milliliter21695-3505fdd1ffa-bd01-43f4-aa7b-31a01e571fe912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
SACCHARININACTIVE INGREDIENTFST467XS7DALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-350ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_071e819b-43cd-48f7-b63e-c891936dcfc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSN071e819b-43cd-48f7-b63e-c891936dcfc41
755497albuterol 0.4 MG/ML Oral SolutionSCD071e819b-43cd-48f7-b63e-c891936dcfc41
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSY071e819b-43cd-48f7-b63e-c891936dcfc41
755497albuterol 2 MG per 5 ML SyrupSY071e819b-43cd-48f7-b63e-c891936dcfc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-350-1621695035016473 mL in 1 BOTTLE473 mlHistorical