Albuterol Sulfate

Product NDC
60687-395
11-digit product format
606870395
Labeler code
60687
Product ID
60687-395_199e7908-e7e3-15d7-e063-6294a90ad53f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
American Health Packaging
Application
ANDA077839
Marketing category
ANDA
Marketing start
2019-01-11
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

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
A077839-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077839-001AN

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 UTC2026-02A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077839-001ALBUTEROL SULFATEEQ 0.083% BASESOLUTION / INHALATIONAN2008-12-16cb3db0bc1861…

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 UTC2026-02A077839-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077839-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077839-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077839-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077839-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077839-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077839-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077839-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077839-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077839-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077839-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077839-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077839-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077839-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077839-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077839-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077839-001AN14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077839-001AN174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077839-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077839-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077839-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03A077839-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077839-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077839-001AN1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077839-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A077839-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077839-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077839-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077839-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077839-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077839-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077839-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077839-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077839-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077839-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077839-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077839-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077839-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077839-001AN1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077839-001AN1cb3db0bc1861…

Additional Listing Data#

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

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
4aec7f59-b429-4b0e-a779-8df1dd8f80d7Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-395-79Albuterol Sulfate3 mL in 1 AMPULESOLUTION34
60687-395-79Albuterol Sulfate1 in 1 POUCHSOLUTION14
60687-395-83Albuterol Sulfate30 in 1 CARTONSOLUTION304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-395-79ML - Milliliter60687-39572f4e20d-4ebe-439f-a5e3-d81acd6e428412019-01-24
60687-395-83ML - Milliliter60687-395ef919537-2602-44d3-afef-587fae8175fc12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-395ALBUTEROL SULFATE SOLUTION [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 3 package rows20240531_4aec7f59-b429-4b0e-a779-8df1dd8f80d7.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATEAmerican Health Packaging4aec7f59-b429-4b0e-a779-8df1dd8f80d72026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
ndc (product): 60687-395
Albuterol SulfateALBUTEROL SULFATERitedose Pharmaceuticals, LLCb72742df-1a6b-4483-aff3-3e79db5e015d2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATECardinal Health 107, LLCd2132c1c-0f90-4c6f-afc0-f3814b6a7e5c2026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATECardinal Health 107, LLC6ec88f64-66a2-4ca9-9913-c192fc33f88b2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.c90e80b2-882e-4c0c-bfac-d67eb1da724d2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATEMylan Pharmaceuticals Inc.5329614f-ae0b-4854-bb6f-ea0b7dae87c02026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals, Inc.2c3f975c-dbd8-0362-e063-6394a90a16dd2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATEA-S Medication Solutions19867b61-77a2-46f1-97c7-7fadfec5882b2024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839
Albuterol SulfateALBUTEROL SULFATEMedical Purchasing Solutions, LLC6a4b4b95-d1d3-9051-e053-2a91aa0a52e82023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077839
application number: ANDA077839

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSN6ec88f64-66a2-4ca9-9913-c192fc33f88b5
630208albuterol 0.83 MG/ML Inhalation SolutionSCD6ec88f64-66a2-4ca9-9913-c192fc33f88b5
630208albuterol 0.083 % Inhalation SolutionSY6ec88f64-66a2-4ca9-9913-c192fc33f88b5
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY6ec88f64-66a2-4ca9-9913-c192fc33f88b5
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY6ec88f64-66a2-4ca9-9913-c192fc33f88b5
630208albuterol sulfate 0.083 % Inhalation SolutionPSN4aec7f59-b429-4b0e-a779-8df1dd8f80d74
630208albuterol 0.83 MG/ML Inhalation SolutionSCD4aec7f59-b429-4b0e-a779-8df1dd8f80d74
630208albuterol 0.083 % Inhalation SolutionSY4aec7f59-b429-4b0e-a779-8df1dd8f80d74
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY4aec7f59-b429-4b0e-a779-8df1dd8f80d74
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY4aec7f59-b429-4b0e-a779-8df1dd8f80d74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-395-79606870395793 mL in 1 AMPULE3 mlHistorical
60687-395-836068703958330 POUCH in 1 CARTON (60687-395-83) / 1 AMPULE in 1 POUCH (60687-395-79) / 3 mL in 1 AMPULE30 pouch2019-01-110000-00-00NoNoCurrent