Home NDC 17856-0620 Baclofen
Product NDC 17856-0620
11-digit product format 178560620
Labeler code 17856
Product ID 17856-0620_50ffb7ff-ed78-1b75-e063-6294a90a00fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form SOLUTION
Route ORAL
Labeler Atlantic Biologicals Corp.
Application NDA208193
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2023-10-12
Substance BACLOFEN
Active strength 10 mg/5mL
Pharmacologic classes GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N208193-001 OZOBAX BACLOFEN 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 N208193-002 OZOBAX DS BACLOFEN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2023-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208193-002 AA
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208193-001 10610502 2039-08-30 U-2779 2020-04-23
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 2 · 57 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 2026-02-19 14:30 UTC 2026-02 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL AA RLD, RS 2023-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL AA RLD, RS 2023-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL AA RLD, RS 2023-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208193-002 OZOBAX DS 10MG/5ML SOLUTION / ORAL RLD, RS 2023-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD, RS 2019-09-18 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208193-001 OZOBAX 5MG/5ML SOLUTION / ORAL RLD 2019-09-18 6a51e52b5d6a…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208193-002 AA 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208193-002 AA 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208193-002 AA 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208193-002 AA 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208193-001 10610502 2039-08-30 U-2779 2020-04-23 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Baclofen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACLOFEN 10 mg/5mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2667941 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 17856-0620-1 Baclofen 2.5 mL in 1 CUP, UNIT-DOSE SOLUTION 2.5 2 17856-0620-1 Baclofen 72 in 1 CASE SOLUTION 72 2 17856-0620-2 Baclofen 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 2 17856-0620-2 Baclofen 72 in 1 CASE SOLUTION 72 2
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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 17856-0620-1 17856062001 72 CUP, UNIT-DOSE in 1 CASE (17856-0620-1) / 2.5 mL in 1 CUP, UNIT-DOSE 2026-04-30 No No Current 17856-0620-2 17856062002 72 CUP, UNIT-DOSE in 1 CASE (17856-0620-2) / 5 mL in 1 CUP, UNIT-DOSE 2026-04-30 No No Current 17856-0620-3 17856062003 1 SYRINGE in 1 BAG (17856-0620-3) / 2.5 mL in 1 SYRINGE 1 syringe 2026-07-14 0 Current 17856-0620-4 17856062004 1 SYRINGE in 1 BAG (17856-0620-4) / 5 mL in 1 SYRINGE 1 syringe 2026-07-14 0 Current