Home NDC 70257-562-55 Lioresal (baclofen)
Product NDC 70257-562
Requested package NDC 70257-562-55
11-digit product format 702570562
Labeler code 70257
Product ID 70257-562_7280e190-0f51-11ed-aa05-0800200c9a66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name baclofen
Dosage form INJECTION
Route INTRATHECAL
Labeler Saol Therapeutics Inc.
Application NDA020075
Marketing category NDA
Marketing start 2022-06-12
Marketing end 2024-11-30
Substance BACLOFEN
Active strength 0 mg/mL
Pharmacologic classes GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 9 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…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020075-001 LIORESAL BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 N020075-002 LIORESAL BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 N020075-003 LIORESAL BACLOFEN 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020075-002 LIORESAL 2MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020075-003 LIORESAL 0.05MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1996-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020075-001 LIORESAL 0.5MG/ML INJECTABLE / INTRATHECAL AP RLD, RS 1992-06-17 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70257-562-55 70257056255 5 AMPULE in 1 BOX (70257-562-55) > 1 mL in 1 AMPULE (70257-562-11) 5 ampule 2022-06-12 2024-11-30 No No Current