Baclofen

Product NDC
29300-343
11-digit product format
293000343
Labeler code
29300
Product ID
29300-343_513de439-4155-4a5d-a25c-bced499e293a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA212067
Marketing category
ANDA
Marketing start
2020-07-09
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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212067-001BACLOFENBACLOFEN10MGTABLET / ORALAB2020-07-09
A212067-002BACLOFENBACLOFEN20MGTABLET / ORALAB2020-07-09
A212067-003BACLOFENBACLOFEN5MGTABLET / ORALAB2023-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212067-001AB
A212067-002AB
A212067-003AB

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 · 97 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212067-002BACLOFEN20MGTABLET / ORALAB2020-07-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212067-003BACLOFEN5MGTABLET / ORALAB2023-03-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212067-001BACLOFEN10MGTABLET / ORALAB2020-07-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 97 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212067-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212067-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212067-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212067-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212067-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212067-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212067-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212067-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212067-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212067-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212067-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212067-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212067-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212067-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212067-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212067-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212067-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212067-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212067-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212067-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212067-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212067-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212067-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212067-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212067-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212067-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212067-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212067-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212067-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212067-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212067-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212067-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212067-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212067-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212067-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212067-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212067-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212067-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212067-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212067-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197391Internal RxNorm lookup
197392Internal RxNorm lookup
430902Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9199878-3fb4-46dc-adbb-b3d9dc3852d4Available 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
29300-343-01Baclofen100 in 1 BOTTLETABLET1006
29300-343-05Baclofen500 in 1 BOTTLETABLET5006
29300-343-10Baclofen1000 in 1 BOTTLETABLET10006
29300-343-19Baclofen90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-343-01EA - Each29300-34305d79499-e3fb-41fe-a666-b4e12c3f499212020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-343BACLOFEN TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]6Current NDC, Legacy NDC, 4 package rows20230615_b9199878-3fb4-46dc-adbb-b3d9dc3852d4.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
BaclofenBACLOFENREMEDYREPACK INC.76896b07-2835-4467-b386-87ec66ddd88e2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENPreferred Pharmaceuticals Inc.3047613d-006b-4011-b5fe-098588f474aa2026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENRedpharm Drug4ce1de84-72e1-57d3-e063-6294a90a220f2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENPreferred Pharmaceuticals Inc.69d0027a-cb46-4754-9225-071ec1ce4b372026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENPHOENIX RX LLC45c6d45d-95d5-21b8-e063-6294a90a79552025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENBryant Ranch Prepackab5fd609-3081-4400-90cd-c83b6834d3812025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENBryant Ranch Prepack8cb96e7b-9c40-46a9-b964-7a573b7a03422025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENBryant Ranch Prepack4b215bc5-f7f9-4b39-b8ee-42b233ee4aa22025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENBryant Ranch Prepack9bbcbf20-57ed-447b-9744-a5f10b9a057a2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENAdvanced Rx of Tennessee, LLC29987a4c-cf5f-4f98-e063-6394a90a7f192024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENBryant Ranch Prepackb5fde991-7d12-4083-a3d6-363718f1f6a12024-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLC19b049cf-56a4-aeaa-e063-6394a90a366d2024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
BaclofenBACLOFENUnichem Pharmaceuticals (USA), Inc.b9199878-3fb4-46dc-adbb-b3d9dc3852d42023-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212067
application number: ANDA212067
ndc (product): 29300-343

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN4b215bc5-f7f9-4b39-b8ee-42b233ee4aa2100
197391baclofen 10 MG Oral TabletSCD4b215bc5-f7f9-4b39-b8ee-42b233ee4aa2100
197391baclofen 10 MG Oral TabletPSNb9199878-3fb4-46dc-adbb-b3d9dc3852d46
197392baclofen 20 MG Oral TabletPSNb9199878-3fb4-46dc-adbb-b3d9dc3852d46
430902baclofen 5 MG Oral TabletPSNb9199878-3fb4-46dc-adbb-b3d9dc3852d46
197391baclofen 10 MG Oral TabletSCDb9199878-3fb4-46dc-adbb-b3d9dc3852d46
197392baclofen 20 MG Oral TabletSCDb9199878-3fb4-46dc-adbb-b3d9dc3852d46
430902baclofen 5 MG Oral TabletSCDb9199878-3fb4-46dc-adbb-b3d9dc3852d46
197391baclofen 10 MG Oral TabletPSN76896b07-2835-4467-b386-87ec66ddd88e5
197391baclofen 10 MG Oral TabletSCD76896b07-2835-4467-b386-87ec66ddd88e5
197391baclofen 10 MG Oral TabletPSNb5fde991-7d12-4083-a3d6-363718f1f6a12
197391baclofen 10 MG Oral TabletPSN69d0027a-cb46-4754-9225-071ec1ce4b372
197391baclofen 10 MG Oral TabletSCDb5fde991-7d12-4083-a3d6-363718f1f6a12
197391baclofen 10 MG Oral TabletSCD69d0027a-cb46-4754-9225-071ec1ce4b372
197391baclofen 10 MG Oral TabletPSN4ce1de84-72e1-57d3-e063-6294a90a220f1
197391baclofen 10 MG Oral TabletPSN19b049cf-56a4-aeaa-e063-6394a90a366d1
197391baclofen 10 MG Oral TabletSCD19b049cf-56a4-aeaa-e063-6394a90a366d1
197391baclofen 10 MG Oral TabletSCD4ce1de84-72e1-57d3-e063-6294a90a220f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-343-0129300034301100 TABLET in 1 BOTTLE (29300-343-01) 100 tablet2020-07-090000-00-00NoNoCurrent
29300-343-0529300034305500 TABLET in 1 BOTTLE (29300-343-05) 500 tablet2020-07-090000-00-00NoNoCurrent
29300-343-10293000343101000 TABLET in 1 BOTTLE (29300-343-10) 1000 tablet2020-07-090000-00-00NoNoCurrent
29300-343-192930003431990 TABLET in 1 BOTTLE (29300-343-19) 90 tablet2022-08-250000-00-00NoNoCurrent