Baclofen

Product NDC
50090-5855
11-digit product format
500905855
Labeler code
50090
Product ID
50090-5855_fbe003fb-fb4f-4f3c-94ce-85d0a195f1b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212378
Marketing category
ANDA
Marketing start
2020-10-09
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-5855DDiscontinued by firm2026-08-03
excluded packagepackage50090-585550090-5855-0DDiscontinued by firm2026-08-03
excluded packagepackage50090-585550090-5855-1DDiscontinued by firm2026-08-03
excluded packagepackage50090-585550090-5855-3DDiscontinued by firm2026-08-03

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-5855-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-5855-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-5855-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5855-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5855-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5855-3f5e01cc5f278…a2eaf40c39c3…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5855-0EA - Each50090-58559c4edf13-69fa-490b-9116-9f0b85ed77c312022-06-06
50090-5855-1EA - Each50090-58552b71dbc5-699a-46e6-b7e8-62d6acc6374c12022-06-06
50090-5855-3EA - Each50090-5855a141401b-a70d-4826-9b00-723375ec6ea212022-06-06

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5855-05009058550060 TABLET in 1 BOTTLE (50090-5855-0) 60 tablet2021-11-110000-00-00NoNoCurrent
50090-5855-15009058550130 TABLET in 1 BOTTLE (50090-5855-1) 30 tablet2021-11-110000-00-00NoNoCurrent
50090-5855-35009058550390 TABLET in 1 BOTTLE (50090-5855-3) 90 tablet2021-11-110000-00-00NoNoCurrent