ALBUTEROL SULFATE

Product NDC
70752-102
11-digit product format
707520102
Labeler code
70752
Product ID
70752-102_f8b35fdc-741f-4ebd-91d5-a55a7ef8e261
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
SYRUP
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA212197
Marketing category
ANDA
Marketing start
2019-09-06
Substance
ALBUTEROL SULFATE
Active strength
2 mg/5mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212197-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212197-001AA

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
2026-08-18 06:07:402026-07A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-063f01610625f2…
2019-09-15 20:21 UTC2019-09A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212197-001ALBUTEROL SULFATEEQ 2MG BASE/5MLSYRUP / ORALAA2019-09-06cb3db0bc1861…

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
2026-08-18 06:07:402026-07A212197-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212197-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212197-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212197-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212197-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212197-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212197-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212197-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212197-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212197-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212197-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212197-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212197-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212197-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212197-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212197-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212197-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212197-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212197-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212197-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212197-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212197-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A212197-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212197-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212197-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212197-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A212197-001AA1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212197-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212197-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212197-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212197-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212197-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212197-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212197-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212197-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212197-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212197-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212197-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212197-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212197-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
ALBUTEROL SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2 mg/5mL

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
755497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99a490cc-e41d-436b-9cf3-8facb7ac714fAvailable 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
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
70752-102-122023-02-15C16284748780-1f386c649-e851-0266-e053-dadaa90a7c1aAlbuterol Sulfate Syrup, 2 mg/5 mL Rx only
70752-102-122023-01-30C16284748780-1f386c649-e851-0266-e053-dadaa90a7c1aAlbuterol Sulfate Syrup, 2 mg/5 mL Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-102-12ALBUTEROL SULFATE473 mL in 1 BOTTLESYRUP4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-102-12ML - Milliliter70752-1021032f295-477f-41cb-a978-d772cfbbfa8112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-102ALBUTEROL SULFATE SYRUP [QUAGEN PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 1 package rows20230216_99a490cc-e41d-436b-9cf3-8facb7ac714f.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 SULFATEBryant Ranch Prepack378461f2-7271-44a3-9da3-b39970b65d3a2025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212197
application number: ANDA212197
ALBUTEROL SULFATEALBUTEROL SULFATEQUAGEN PHARMACEUTICALS LLC99a490cc-e41d-436b-9cf3-8facb7ac714f2025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212197
application number: ANDA212197
ndc (product): 70752-102
ALBUTEROL SULFATEALBUTEROL SULFATEPreferred Pharmaceuticals, Inc.4aafc2dd-744d-4726-828f-70355aee6f702025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212197
application number: ANDA212197
ALBUTEROL SULFATEALBUTEROL SULFATEBryant Ranch Prepack45e07bdd-78f9-4055-9de3-646e67de7eaf2024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212197
application number: ANDA212197

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSN45e07bdd-78f9-4055-9de3-646e67de7eaf101
755497albuterol 0.4 MG/ML Oral SolutionSCD45e07bdd-78f9-4055-9de3-646e67de7eaf101
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSY45e07bdd-78f9-4055-9de3-646e67de7eaf101
755497albuterol 2 MG per 5 ML SyrupSY45e07bdd-78f9-4055-9de3-646e67de7eaf101
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSN378461f2-7271-44a3-9da3-b39970b65d3a100
755497albuterol 0.4 MG/ML Oral SolutionSCD378461f2-7271-44a3-9da3-b39970b65d3a100
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSY378461f2-7271-44a3-9da3-b39970b65d3a100
755497albuterol 2 MG per 5 ML SyrupSY378461f2-7271-44a3-9da3-b39970b65d3a100
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSN4aafc2dd-744d-4726-828f-70355aee6f706
755497albuterol 0.4 MG/ML Oral SolutionSCD4aafc2dd-744d-4726-828f-70355aee6f706
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSY4aafc2dd-744d-4726-828f-70355aee6f706
755497albuterol 2 MG per 5 ML SyrupSY4aafc2dd-744d-4726-828f-70355aee6f706
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSN99a490cc-e41d-436b-9cf3-8facb7ac714f3
755497albuterol 0.4 MG/ML Oral SolutionSCD99a490cc-e41d-436b-9cf3-8facb7ac714f3
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSY99a490cc-e41d-436b-9cf3-8facb7ac714f3
755497albuterol 2 MG per 5 ML SyrupSY99a490cc-e41d-436b-9cf3-8facb7ac714f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-102-1270752010212473 mL in 1 BOTTLE (70752-102-12) 473 ml2019-09-060000-00-00NoNoCurrent