Home NDC 53746-540 CYCLOBENZAPRINE HYDROCHLORIDE
Product NDC 53746-540
11-digit product format 537460540
Labeler code 53746
Product ID 53746-540_b0e32570-da9f-4fa8-a0a2-0334fce7ff7a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA078218
Marketing category ANDA
Marketing start 2010-02-18
Substance CYCLOBENZAPRINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
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 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03
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 · 124 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 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078218-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078218-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-11-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078218-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-04-18 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 124 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0VE05JYS2P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 828320 Internal RxNorm lookup 828348 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 53746-540-01 CYCLOBENZAPRINE HYDROCHLORIDE 100 in 1 BOTTLE TABLET, FILM COATED 100 6 53746-540-05 CYCLOBENZAPRINE HYDROCHLORIDE 500 in 1 BOTTLE TABLET, FILM COATED 500 6 53746-540-10 CYCLOBENZAPRINE HYDROCHLORIDE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-540 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 6 Current NDC, Legacy NDC, 3 package rows 20240101_31bb92f6-ec8c-4636-8b07-8814417fe78e.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53746-540-01 53746054001 100 TABLET, FILM COATED in 1 BOTTLE (53746-540-01) 2010-02-18 0000-00-00 No No Current 53746-540-05 53746054005 500 TABLET, FILM COATED in 1 BOTTLE (53746-540-05) 2010-02-18 0000-00-00 No No Current 53746-540-10 53746054010 1000 TABLET, FILM COATED in 1 BOTTLE (53746-540-10) 2010-02-18 0000-00-00 No No Current