Home NDC 70121-2501 Lioresal (baclofen)
Product NDC 70121-2501
11-digit product format 701212501
Labeler code 70121
Product ID 70121-2501_d68a08e0-d0d9-4144-be01-47b636dfa7e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name baclofen
Dosage form KIT
Route INTRATHECAL
Labeler Amneal Pharmaceuticals LLC
Application NDA020075
Marketing category NDA
Marketing start 2022-06-12
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Lioresal (baclofen)
Listing expiration 2026-12-31 Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H789N3FKE8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308516 Internal RxNorm lookup 308517 Internal RxNorm lookup 805678 Internal RxNorm lookup 805679 Internal RxNorm lookup 1666613 Internal RxNorm lookup 1666620 Internal RxNorm lookup 1666622 Internal RxNorm lookup 1666623 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70121-2501-1 Lioresal (baclofen) 1 in 1 AMPULE KIT 1 29 70121-2501-1 Lioresal (baclofen) 1 in 1 BOX KIT 1 29
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-2501 LIORESAL (BACLOFEN) (BACLOFEN) KIT LIORESAL (BACLOFEN) (BACLOFEN) INJECTION [AMNEAL PHARMACEUTICALS LLC] 26 Current NDC, Legacy NDC, 2 package rows 20241211_6f3bdcc0-ffc8-4911-8c35-958c8103a2c5.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 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 308517 baclofen 10 MG in 20 ML (500 MCG/ML) Injection PSN 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666622 baclofen 10 MG in 5 ML (2,000 MCG/ML) Injection PSN 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666613 baclofen 40 MG in 20 ML (2,000 MCG/ML) Injection PSN 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 805679 LIORESAL INTRATHECAL 0.05 MG in 1 ML (50 MCG/ML) Injection PSN 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 805678 LIORESAL INTRATHECAL 10 MG in 20 ML (500 MCG/ML) Injection PSN 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666623 LIORESAL INTRATHECAL 10 MG in 5 ML (2,000 MCG/ML) Injection PSN 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666620 LIORESAL INTRATHECAL 40 MG in 20 ML (2,000 MCG/ML) Injection PSN 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 805679 1 ML baclofen 0.05 MG/ML Injection [Lioresal] SBD 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 805678 20 ML baclofen 0.5 MG/ML Injection [Lioresal] SBD 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666620 20 ML baclofen 2 MG/ML Injection [Lioresal] SBD 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666623 5 ML baclofen 2 MG/ML Injection [Lioresal] SBD 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 308516 1 ML baclofen 0.05 MG/ML Injection SCD 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 308517 20 ML baclofen 0.5 MG/ML Injection SCD 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666613 20 ML baclofen 2 MG/ML Injection SCD 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666622 5 ML baclofen 2 MG/ML Injection SCD 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 805679 1 ML Lioresal 0.05 MG/ML Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 805678 20 ML Lioresal 0.5 MG/ML Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666620 20 ML Lioresal 2 MG/ML Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666623 5 ML Lioresal 2 MG/ML Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 308516 baclofen 0.05 MG per 1 ML Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666622 baclofen 10 MG per 5 ML (2,000 MCG/ML) Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 308517 baclofen 10,000 MCG per 20 ML Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666613 baclofen 40,000 MCG per 20 ML Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 308516 baclofen 50 MCG per 1 ML Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 805679 Lioresal 0.05 MG per 1 ML Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 805678 Lioresal 10 MG per 20 ML (500 MCG/ML) Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666623 Lioresal 10 MG per 5 ML (2,000 MCG/ML) Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 1666620 Lioresal 40 MG per 20 ML (2,000 MCG/ML) Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29 805679 Lioresal 50 MCG per 1 ML Injection SY 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 29
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70121-2501-1 70121250101 1 AMPULE in 1 BOX (70121-2501-1) / 1 KIT in 1 AMPULE 1 ampule 2022-06-12 2024-11-30 No No Current