Baclofen

Product NDC
45865-355
11-digit product format
458650355
Labeler code
45865
Product ID
45865-355_9adb5c2f-69b8-4c26-e053-2995a90aa4af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA077241
Marketing category
ANDA
Marketing start
2005-12-01
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
20 mg/1
Pharmacologic classes
GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct45865-355IInactivated by FDA2026-08-10
excluded packagepackage45865-35545865-355-51IInactivated by FDA2026-08-10

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-355-51IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-355-51IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-355-51IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-355-51IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-355-51IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-355-51IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-355-51UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-355-51UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-355-51UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077241-001BACLOFENBACLOFEN20MGTABLET / ORALAB2005-12-20
A077241-002BACLOFENBACLOFEN10MGTABLET / ORALAB2007-07-06
A077241-003BACLOFENBACLOFEN5MGTABLET / ORALAB2021-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077241-001AB
A077241-002AB
A077241-003AB

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 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077241-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077241-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077241-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077241-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077241-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077241-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077241-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077241-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077241-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077241-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-355-512025-01-30C16284748780-12cef2736-b5fa-d83d-e063-dadaa90ab31fBACLOFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-355-51Baclofen120 in 1 BOTTLE, PLASTICTABLET1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-355BACLOFEN TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191230_9adb5c2f-69b7-4c26-e053-2995a90aa4af.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENCardinal Health 107, LLC2278954a-7605-426a-ae85-1bf0a31174202026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENMajor Pharmaceuticalsae732bdc-5178-4565-8219-d1787a5211a62026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENPD-Rx Pharmaceuticals, Inc.cfcf519f-5d15-431d-89c8-961a0c38ba602025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENMarlex Pharmaceuticals Inc1b0f50c8-62e3-414d-96d3-5fd16e8043ab2025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCb4f2f888-979a-6f54-e053-2a95a90a95a32024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENChartwell RX, LLC2a75db96-590a-43cf-aefb-3bbcb287dbf02024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENBryant Ranch Prepack7f27f935-b1fa-4494-9014-7f62c59bb8e32024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENBryant Ranch Prepackb4506087-be24-4e76-9fb8-b078051370722024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCc582972d-22ef-4326-b37f-adf2ca0b18752023-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENBryant Ranch Prepack58816b46-28a5-48e2-b89d-98df659393862023-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENBryant Ranch Prepack9110b1cb-8604-4824-9337-84b08d41dd3c2023-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENLannett Company, Inc.f84f3f4c-17e6-43f1-9600-63b0b175837b2021-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENProficient Rx LP924a01fb-0ed0-4f73-9304-d6c5b9961d662020-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN9adb5c2f-69b7-4c26-e053-2995a90aa4af1
197392baclofen 20 MG Oral TabletSCD9adb5c2f-69b7-4c26-e053-2995a90aa4af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-355-5145865035551120 TABLET in 1 BOTTLE, PLASTIC (45865-355-51) 120 tablet2018-12-120000-00-00NoNoCurrent