Baclofen

Product NDC
80425-0282
Requested package NDC
80425-0282-3
11-digit product format
804250282
Labeler code
80425
Product ID
80425-0282_26f8bbf8-7c53-4c19-e063-6394a90a5a4a
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
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
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…

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
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
ndc (package): 80425-0282-3
ndc (product): 80425-0282
ndc11 (package): 80425028203
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN20 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
197392Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5edb656-4f7e-2386-e053-2995a90a70deAvailable 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
80425-0282-1Baclofen30 in 1 BOTTLETABLET302
80425-0282-2Baclofen60 in 1 BOTTLETABLET602
80425-0282-3Baclofen90 in 1 BOTTLETABLET902
80425-0282-4Baclofen120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0282-1EA - Each80425-02826dc60c48-2657-425f-bc48-f4f28897157712023-04-07
80425-0282-2EA - Each80425-028242f8d368-b537-40b6-9557-e8544b27c1ca12023-04-07
80425-0282-3EA - Each80425-0282b6333d87-6abb-4774-9644-0242ac576cf112023-04-07
80425-0282-4EA - Each80425-0282f179f3fc-b772-4532-8048-9a3dba92b73c12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0282BACLOFEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 4 package rows20241116_f5edb656-4f7e-2386-e053-2995a90a70de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSNf5edb656-4f7e-2386-e053-2995a90a70de2
197392baclofen 20 MG Oral TabletSCDf5edb656-4f7e-2386-e053-2995a90a70de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0282-38042502820390 TABLET in 1 BOTTLE (80425-0282-3) 90 tablet2020-10-09NoNoCurrent