BACLOFEN

Product NDC
70518-3614
11-digit product format
705183614
Labeler code
70518
Product ID
70518-3614_4f6b3ea4-9fcf-af92-e063-6394a90abb28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209102
Marketing category
ANDA
Marketing start
2023-01-09
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
2027-12-31
Current FDA listing
Yes

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 packagepackage70518-361470518-3614-0DDiscontinued by firm2026-08-17

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-361470518-3614-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209102-001BACLOFENBACLOFEN5MGTABLET / ORALAB2017-11-28
A209102-002BACLOFENBACLOFEN10MGTABLET / ORALAB2017-11-28
A209102-003BACLOFENBACLOFEN20MGTABLET / ORALAB2017-11-28
A209102-004BACLOFENBACLOFEN15MGTABLET / ORALAB2024-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A209102-001AB
A209102-002AB
A209102-003AB
A209102-004AB

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 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209102-001BACLOFEN5MGTABLET / ORALAB2017-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A209102-002BACLOFEN10MGTABLET / ORALAB2017-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A209102-003BACLOFEN20MGTABLET / ORALAB2017-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A209102-004BACLOFEN15MGTABLET / ORALAB2024-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209102-001BACLOFEN5MGTABLET / ORALAB2017-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209102-002BACLOFEN10MGTABLET / ORALAB2017-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209102-003BACLOFEN20MGTABLET / ORALAB2017-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209102-004BACLOFEN15MGTABLET / ORALAB2024-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209102-001BACLOFEN5MGTABLET / ORALABRS2017-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209102-002BACLOFEN10MGTABLET / ORALAB2017-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209102-003BACLOFEN20MGTABLET / ORALAB2017-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209102-004BACLOFEN15MGTABLET / ORALAB2024-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209102-001BACLOFEN5MGTABLET / ORALABRS2017-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209102-002BACLOFEN10MGTABLET / ORALAB2017-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209102-003BACLOFEN20MGTABLET / ORALAB2017-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209102-004BACLOFEN15MGTABLET / ORALAB2024-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209102-001BACLOFEN5MGTABLET / ORALABRS2017-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209102-002BACLOFEN10MGTABLET / ORALAB2017-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209102-003BACLOFEN20MGTABLET / ORALAB2017-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209102-004BACLOFEN15MGTABLET / ORALAB2024-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209102-001BACLOFEN5MGTABLET / ORALABRS2017-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209102-002BACLOFEN10MGTABLET / ORALAB2017-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209102-003BACLOFEN20MGTABLET / ORALAB2017-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209102-004BACLOFEN15MGTABLET / ORALAB2024-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209102-001BACLOFEN5MGTABLET / ORALABRS2017-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209102-002BACLOFEN10MGTABLET / ORALAB2017-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209102-003BACLOFEN20MGTABLET / ORALAB2017-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209102-004BACLOFEN15MGTABLET / ORALAB2024-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209102-001BACLOFEN5MGTABLET / ORALABRS2017-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209102-002BACLOFEN10MGTABLET / ORALAB2017-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209102-003BACLOFEN20MGTABLET / ORALAB2017-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209102-004BACLOFEN15MGTABLET / ORALAB2024-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209102-001BACLOFEN5MGTABLET / ORALABRS2017-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209102-002BACLOFEN10MGTABLET / ORALAB2017-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209102-003BACLOFEN20MGTABLET / ORALAB2017-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209102-004BACLOFEN15MGTABLET / ORALAB2024-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209102-001BACLOFEN5MGTABLET / ORALABRS2017-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209102-002BACLOFEN10MGTABLET / ORALAB2017-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209102-003BACLOFEN20MGTABLET / ORALAB2017-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209102-004BACLOFEN15MGTABLET / ORALAB2024-02-05d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 139 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209102-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209102-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209102-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209102-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209102-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209102-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209102-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209102-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209102-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209102-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209102-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209102-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209102-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209102-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209102-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209102-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209102-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209102-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209102-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209102-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209102-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209102-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209102-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209102-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209102-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209102-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209102-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209102-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209102-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209102-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209102-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209102-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209102-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209102-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209102-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209102-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209102-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209102-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209102-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209102-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H789N3FKE8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197391Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac9b720f-b755-49f1-9850-efb26feadaebAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3614-0BACLOFEN30 in 1 BLISTER PACKTABLET308
70518-3614-1BACLOFEN90 in 1 BOTTLE, PLASTICTABLET908
70518-3614-2BACLOFEN30 in 1 BOTTLE, PLASTICTABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3614-1EA - Each70518-3614bfda1458-fcf3-48cd-b519-e0c357f63b0b12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3614BACLOFEN TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20241122_ac9b720f-b755-49f1-9850-efb26feadaeb.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACLOFENBACLOFENREMEDYREPACK INC.ac9b720f-b755-49f1-9850-efb26feadaeb2026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
ndc (product): 70518-3614
BACLOFENBACLOFENRedpharm Drug53df4b4b-842e-9e3a-e063-6394a90a8a3d2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENREMEDYREPACK INC.e017a001-8cb1-4dd8-960e-c6d74005f57f2026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.ee59a379-17d5-487f-b72f-a53e74744a702026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.91175128-8285-4d04-89a9-219781be92602026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.16266972-843e-4ea5-be1f-fb1b1588a5dc2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.0a1d09ac-94d5-45ef-92cc-bc261c2b2d752026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENMajor Pharmaceuticals46f84504-ffc4-4be5-9598-c20a3f4210f42026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENAdvagen Pharma Limited04dac0f6-cc6c-4959-9bca-a6e4a99690f32026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENREMEDYREPACK INC.00c6c924-ddfd-4a75-afd7-f6561ff9abbc2026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENAdvanced Rx of Tennessee, LLC459ec5f5-4f99-e917-e063-6294a90a23cd2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENSOLA Pharmaceuticals, LLC7b308b35-8c08-458d-860e-c78d057e82602025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENProficient Rx LP0680301a-1649-46c4-b74e-ab03967945d02025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENPD-Rx Pharmaceuticals, Inc.5cba5255-e5ad-48fd-8385-60e9ea6b64072025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENREMEDYREPACK INC.4e2cd27d-91c7-4f15-96cc-3971769dbeaa2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENAsclemed USA, Inc.35bccefe-8d2e-85b5-e063-6394a90a58ca2025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENA-S Medication Solutionseb690a49-b87b-433f-9afe-2966406fe00e2025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENA-S Medication Solutionsaf0ade6c-9dd4-42d3-879e-4201fbe585ee2025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BACLOFENBACLOFENProficient Rx LP0243dd97-1d40-48f7-8853-76e046c605f22025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102
BaclofenBACLOFENDirect_Rx020632f4-5e8a-f4a0-e063-6294a90a63012025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209102
application number: ANDA209102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNac9b720f-b755-49f1-9850-efb26feadaeb8
197391baclofen 10 MG Oral TabletSCDac9b720f-b755-49f1-9850-efb26feadaeb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3614-07051836140030 TABLET in 1 BLISTER PACK (70518-3614-0) 30 tablet2023-01-090000-00-00NoNoCurrent
70518-3614-17051836140190 TABLET in 1 BOTTLE, PLASTIC (70518-3614-1) 90 tablet2023-08-31NoNoCurrent
70518-3614-27051836140230 TABLET in 1 BOTTLE, PLASTIC (70518-3614-2) 30 tablet2023-09-27NoNoCurrent