Terbutaline Sulfate

Product NDC
10135-579
Requested package NDC
10135-579-32
11-digit product format
101350579
Labeler code
10135
Product ID
10135-579_500ad3da-ce1b-4289-acdd-be3ec36577fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbutaline Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA077152
Marketing category
ANDA
Marketing start
2014-10-01
Marketing end
0000-00-00
Substance
TERBUTALINE SULFATE
Active strength
3 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10135-57910135-579-32IInactivated by FDA2026-08-17

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 · 19 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077152-001TERBUTALINE SULFATETERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-25
A077152-002TERBUTALINE SULFATETERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077152-001AB
A077152-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077152-001TERBUTALINE SULFATE2.5MGTABLET / ORALAB2005-03-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077152-002TERBUTALINE SULFATE5MGTABLET / ORALABRS2005-03-25bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077152-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077152-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077152-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077152-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077152-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077152-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077152-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077152-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077152-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077152-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077152-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077152-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077152-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077152-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077152-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077152-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077152-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077152-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077152-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077152-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077152-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077152-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077152-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077152-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077152-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077152-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077152-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077152-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077152-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077152-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077152-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077152-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077152-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077152-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077152-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077152-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077152-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077152-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077152-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077152-002AB1bb7c543d1eb4…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
49ccb555-d142-0761-ee45-2e1304b37b1dProduct name220210111
a3c04a67-87ea-e8b8-0458-db8085ac6340Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-579-01Terbutaline Sulfate100 in 1 BOTTLETABLET1003
10135-579-10Terbutaline Sulfate1000 in 1 BOTTLETABLET10003
10135-579-32Terbutaline Sulfate180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-579-01EA - Each10135-57975cce4ea-5a04-4e32-a0cc-1dcf1e49ffa512015-04-03
10135-579-32EA - Each10135-579aefe59ff-9284-4d85-a9e7-926f6b4e11f412015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERBUTALINE SULFATEACTIVE INGREDIENT576PU70Y8ETERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
TERBUTALINEACTIVE MOIETYN8ONU3L3PGTERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ETERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-579TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 3 package rows20200107_94742710-e87e-4e1c-85ee-0a2e7a77f0de.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terbutaline SulfateTERBUTALINE SULFATEChartwell RX, LLC.859267c6-3d14-4123-9b9d-4fc248f097262025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077152
application number: ANDA077152
Terbutaline SulfateTERBUTALINE SULFATELannett Company, Inc.fbf54709-5857-4dbc-9233-ebd7abff88c82020-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077152
application number: ANDA077152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857677terbutaline sulfate 2.5 MG Oral TabletPSN94742710-e87e-4e1c-85ee-0a2e7a77f0de3
857683terbutaline sulfate 5 MG Oral TabletPSN94742710-e87e-4e1c-85ee-0a2e7a77f0de3
857677terbutaline sulfate 2.5 MG Oral TabletSCD94742710-e87e-4e1c-85ee-0a2e7a77f0de3
857683terbutaline sulfate 5 MG Oral TabletSCD94742710-e87e-4e1c-85ee-0a2e7a77f0de3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-579-3210135057932180 TABLET in 1 BOTTLE (10135-579-32) 180 tablet2014-10-010000-00-00NoNoCurrent