Baclofen

Product NDC
50436-9022
Requested package NDC
50436-9022-2
11-digit product format
504369022
Labeler code
50436
Product ID
50436-9022_09d2deae-1b90-4d32-8d8e-390a5e193d18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA072234
Marketing category
ANDA
Marketing start
1988-07-21
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
10 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
2022-12-31
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 packagepackage50436-902250436-9022-2IInactivated 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 · 17 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

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
A072234-001BACLOFENBACLOFEN10MGTABLET / ORALAB1988-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072234-001AB

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 UTC2026-02A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-213f01610625f2…
2019-09-15 20:21 UTC2019-09A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072234-001BACLOFEN10MGTABLET / ORALAB1988-07-21cb3db0bc1861…

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 UTC2026-02A072234-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072234-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072234-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072234-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072234-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072234-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072234-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072234-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072234-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072234-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072234-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072234-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072234-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072234-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072234-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072234-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072234-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072234-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072234-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072234-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072234-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072234-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072234-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072234-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072234-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072234-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072234-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072234-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072234-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072234-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072234-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072234-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072234-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072234-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072234-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072234-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072234-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072234-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072234-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072234-001AB1cb3db0bc1861…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-9022-1Baclofen30 in 1 BOTTLETABLET306
50436-9022-2Baclofen60 in 1 BOTTLETABLET606
50436-9022-3Baclofen90 in 1 BOTTLETABLET906
50436-9022-5Baclofen120 in 1 BOTTLETABLET1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-9022-1EA - Each50436-9022b601187d-7cb5-4573-a3f1-19a0769a8dbf12013-04-01
50436-9022-2EA - Each50436-902212d1661d-052f-445a-af04-48dac0b0406312013-04-01
50436-9022-3EA - Each50436-9022ad40be83-c66b-47dc-ab20-bb1934a44c9912014-11-05
50436-9022-5EA - Each50436-9022a502707e-9929-40d1-8684-0673b11ef00212015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [UNIT DOSE SERVICES]3
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [UNIT DOSE SERVICES]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBACLOFEN TABLET [UNIT DOSE SERVICES]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPBACLOFEN TABLET [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [UNIT DOSE SERVICES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [UNIT DOSE SERVICES]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BACLOFEN TABLET [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9022BACLOFEN TABLET [UNIT DOSE SERVICES]6Legacy NDC, 4 package rows20210325_ec9c8b7f-9fb0-4274-9532-2fee335c055d.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENNorthwind Health Company, LLC06bcfb08-2ada-f803-e063-6394a90a826b2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072234
application number: ANDA072234
BaclofenBACLOFENPD-Rx Pharmaceuticals, Inc.95755a7b-4a9f-45ea-a381-d3f661150efe2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072234
application number: ANDA072234
BaclofenBACLOFENAdvanced Rx of Tennessee, LLCb33c4164-e607-2e27-e053-2a95a90ad7db2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072234
application number: ANDA072234
BaclofenBACLOFENProficient Rx LPb981eb16-a195-41da-a186-3e91b63b2def2024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072234
application number: ANDA072234
BaclofenBACLOFENTeva Pharmaceuticals USA, Inc.5648c772-50cb-4961-996e-e68a8eb699ea2019-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072234
application number: ANDA072234

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNec9c8b7f-9fb0-4274-9532-2fee335c055d6
197391baclofen 10 MG Oral TabletSCDec9c8b7f-9fb0-4274-9532-2fee335c055d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-9022-25043690220260 TABLET in 1 BOTTLE (50436-9022-2) 60 tablet2021-03-240000-00-00NoNoCurrent