Baclofen

Product NDC
80425-0156
11-digit product format
804250156
Labeler code
80425
Product ID
80425-0156_2a99a7c1-c4c2-2b01-e063-6294a90aa3b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA212378
Marketing category
ANDA
Marketing start
2020-10-09
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
A212378-001BACLOFENBACLOFEN10MGTABLET / ORALAB2020-10-09
A212378-002BACLOFENBACLOFEN20MGTABLET / ORALAB2020-10-09
A212378-003BACLOFENBACLOFEN5MGTABLET / ORALAB2021-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212378-001AB
A212378-002AB
A212378-003AB

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 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212378-002BACLOFEN20MGTABLET / ORALAB2020-10-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212378-003BACLOFEN5MGTABLET / ORALAB2021-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212378-001BACLOFEN10MGTABLET / ORALAB2020-10-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212378-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212378-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212378-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212378-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212378-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212378-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212378-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212378-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212378-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212378-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212378-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212378-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212378-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212378-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212378-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212378-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212378-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212378-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212378-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212378-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212378-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212378-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212378-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212378-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212378-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212378-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212378-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212378-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212378-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212378-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212378-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212378-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212378-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212378-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212378-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212378-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212378-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212378-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212378-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212378-001AB18072bd15b7f6…

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 · 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
c85a1884-f46f-5cd4-e053-2a95a90a3e27Available 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
80425-0156-1Baclofen30 in 1 BOTTLETABLET308
80425-0156-2Baclofen60 in 1 BOTTLETABLET608
80425-0156-3Baclofen90 in 1 BOTTLETABLET908
80425-0156-4Baclofen120 in 1 BOTTLETABLET1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0156-1EA - Each80425-01563976bbb9-2729-4421-a1ab-2aad461ccdeb12023-03-13
80425-0156-2EA - Each80425-015658dad518-350d-48fc-a31e-10098afab1c212023-03-13
80425-0156-3EA - Each80425-015689c4befc-ce82-4630-99ac-15ba461d79eb12023-03-13
80425-0156-4EA - Each80425-01565e0c1126-6a62-4faa-a161-ce753996297712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0156BACLOFEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 4 package rows20250101_c85a1884-f46f-5cd4-e053-2a95a90a3e27.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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENREMEDYREPACK INC.6274e70a-fb57-461b-b1bc-39d4ff916b2a2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENREMEDYREPACK INC.d689d32c-12a7-4ae4-afc3-8a353be671482026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepack80b0a41e-2cad-4e14-9605-0cd35f9991e92026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepack808113db-c5c2-404c-ab5f-62b991641cfe2026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepack8a39dbc7-99d7-49e4-b5a1-cf70e7d753b22025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepack0a5940cd-63eb-4d1b-8e92-44df264bc05a2025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENMethod Pharmaceuticals LLC1a9db542-d2b0-141a-e063-6394a90acc112025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepacka748da19-d3eb-499e-986c-2043a1356f2b2025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepack3ac0f0d2-86d8-46d0-88e5-c243734b08142025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BACLOFENBACLOFENXLCare Pharmaceuticals Inc.2b4908fb-47b5-4675-be9e-ca1ad48a72522025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCc85a1884-f46f-5cd4-e053-2a95a90a3e272024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
ndc (product): 80425-0156
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCec09736a-dd2b-0a3b-e053-2995a90a95422024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepack43cafbdb-6927-45f6-9b16-3b125cc2a29d2024-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCf5edb656-4f7e-2386-e053-2995a90a70de2024-11-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepack08a6866f-b127-482f-9f22-113175487bdd2024-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepack4634093b-6def-41d6-a7f3-23040125c4f42024-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepack655db2a3-daf7-4f4b-8f64-4a6d81fdc1652024-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepackd24135b3-e247-412f-a10b-ceecbdee3aef2024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepack80a4c6f7-4f02-493c-9263-62e1c90404ba2024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378
BaclofenBACLOFENBryant Ranch Prepackff8e9fa8-5f06-4902-b1ac-a7fc09ccddbb2024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212378
application number: ANDA212378

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNc85a1884-f46f-5cd4-e053-2a95a90a3e278
197391baclofen 10 MG Oral TabletSCDc85a1884-f46f-5cd4-e053-2a95a90a3e278

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0156-18042501560130 TABLET in 1 BOTTLE (80425-0156-1) 30 tablet2020-10-090000-00-00NoNoCurrent
80425-0156-28042501560260 TABLET in 1 BOTTLE (80425-0156-2) 60 tablet2020-10-090000-00-00NoNoCurrent
80425-0156-38042501560390 TABLET in 1 BOTTLE (80425-0156-3) 90 tablet2020-10-090000-00-00NoNoCurrent
80425-0156-480425015604120 TABLET in 1 BOTTLE (80425-0156-4) 120 tablet2023-05-18NoNoCurrent