Home NDC 67457-562-20 Baclofen
Product NDC 67457-562
Requested package NDC 67457-562-20
11-digit product format 674570562
Labeler code 67457
Product ID 67457-562_024758c9-c94b-4ebe-8e7e-a47c39488e74
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form INJECTION, SOLUTION
Route INTRATHECAL
Labeler Mylan Institutional LLC
Application ANDA209592
Marketing category ANDA
Marketing start 2018-12-21
Marketing end 0000-00-00
Substance BACLOFEN
Active strength 10 mg/20mL
Pharmacologic classes GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209592-001 BACLOFEN BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 A209592-002 BACLOFEN BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209592-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209592-002 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2018-03-21 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-562 BACLOFEN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 5 Legacy NDC 20241215_469be477-1379-416a-a492-3ebbcc4a6a84.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67457-562-20 67457056220 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-562-20) > 20 mL in 1 VIAL, SINGLE-DOSE 2018-12-21 0000-00-00 No No Current