Home NDC 58281-561 Lioresal
Product NDC 58281-561
11-digit product format 582810561
Labeler code 58281
Product ID 58281-561_824b1807-be48-4239-bfdc-2d1d15b42c71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name baclofen
Dosage form INJECTION
Route INTRATHECAL
Labeler Medtronic Neuromodulation
Application NDA020075
Marketing category NDA
Marketing start 1992-06-17
Marketing end 0000-00-00
Substance BACLOFEN
Active strength 2 mg/mL
Pharmacologic classes GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58281-561-02 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58281-561-02 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58281-561-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58281-561-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58281-561-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58281-561-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58281-561-02 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58281-561-02 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58281-561-02 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58281-561-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58281-561-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58281-561-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58281-561-02 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58281-561-02 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58281-561-02 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 58281-561-02 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 58281-561-02 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 58281-561-02 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58281-561-02 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58281-561-02 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58281-561-02 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58281-561-02 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58281-561-02 Lioresal 2 in 1 PACKAGE, COMBINATION INJECTION 2 12 58281-561-02 Lioresal 5 mL in 1 AMPULE INJECTION 5 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58281-561 LIORESAL (BACLOFEN) INJECTION [MEDTRONIC NEUROMODULATION] 12 Legacy NDC, 2 package rows 20161013_351cde63-00fa-404a-92df-cb055e991840.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 308516 baclofen 0.05 MG in 1 ML (50 MCG/ML) Injection PSN 351cde63-00fa-404a-92df-cb055e991840 12 308517 baclofen 10 MG in 20 ML (500 MCG/ML) Injection PSN 351cde63-00fa-404a-92df-cb055e991840 12 1666622 baclofen 10 MG in 5 ML (2,000 MCG/ML) Injection PSN 351cde63-00fa-404a-92df-cb055e991840 12 1666613 baclofen 40 MG in 20 ML (2,000 MCG/ML) Injection PSN 351cde63-00fa-404a-92df-cb055e991840 12 805679 LIORESAL INTRATHECAL 0.05 MG in 1 ML (50 MCG/ML) Injection PSN 351cde63-00fa-404a-92df-cb055e991840 12 805678 LIORESAL INTRATHECAL 10 MG in 20 ML (500 MCG/ML) Injection PSN 351cde63-00fa-404a-92df-cb055e991840 12 1666623 LIORESAL INTRATHECAL 10 MG in 5 ML (2,000 MCG/ML) Injection PSN 351cde63-00fa-404a-92df-cb055e991840 12 1666620 LIORESAL INTRATHECAL 40 MG in 20 ML (2,000 MCG/ML) Injection PSN 351cde63-00fa-404a-92df-cb055e991840 12 805679 1 ML baclofen 0.05 MG/ML Injection [Lioresal] SBD 351cde63-00fa-404a-92df-cb055e991840 12 805678 20 ML baclofen 0.5 MG/ML Injection [Lioresal] SBD 351cde63-00fa-404a-92df-cb055e991840 12 1666620 20 ML baclofen 2 MG/ML Injection [Lioresal] SBD 351cde63-00fa-404a-92df-cb055e991840 12 1666623 5 ML baclofen 2 MG/ML Injection [Lioresal] SBD 351cde63-00fa-404a-92df-cb055e991840 12 308516 1 ML baclofen 0.05 MG/ML Injection SCD 351cde63-00fa-404a-92df-cb055e991840 12 308517 20 ML baclofen 0.5 MG/ML Injection SCD 351cde63-00fa-404a-92df-cb055e991840 12 1666613 20 ML baclofen 2 MG/ML Injection SCD 351cde63-00fa-404a-92df-cb055e991840 12 1666622 5 ML baclofen 2 MG/ML Injection SCD 351cde63-00fa-404a-92df-cb055e991840 12 805679 1 ML Lioresal 0.05 MG/ML Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 805678 20 ML Lioresal 0.5 MG/ML Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 1666620 20 ML Lioresal 2 MG/ML Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 1666623 5 ML Lioresal 2 MG/ML Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 308516 baclofen 0.05 MG per 1 ML Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 1666622 baclofen 10 MG per 5 ML (2,000 MCG/ML) Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 308517 baclofen 10,000 MCG per 20 ML Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 1666613 baclofen 40,000 MCG per 20 ML Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 308516 baclofen 50 MCG per 1 ML Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 805679 Lioresal 0.05 MG per 1 ML Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 805678 Lioresal 10 MG per 20 ML (500 MCG/ML) Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 1666623 Lioresal 10 MG per 5 ML (2,000 MCG/ML) Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 1666620 Lioresal 40 MG per 20 ML (2,000 MCG/ML) Injection SY 351cde63-00fa-404a-92df-cb055e991840 12 805679 Lioresal 50 MCG per 1 ML Injection SY 351cde63-00fa-404a-92df-cb055e991840 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 58281-561-02 58281056102 2 in 1 PACKAGE, COMBINATION Historical