Home NDC 76420-269-02 Cyclobenzaprine Hydrochloride
Product NDC 76420-269
Requested package NDC 76420-269-02
11-digit product format 764200269
Labeler code 76420
Product ID 76420-269_e7bfa09d-7e18-d2bf-e053-2995a90a9145
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA071611
Marketing category ANDA
Marketing start 2021-07-20
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 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03
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 · 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 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 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 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 828299 Internal RxNorm lookup 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 76420-269-01 Cyclobenzaprine Hydrochloride 1 in 1 BOTTLE TABLET, FILM COATED 1 1 76420-269-02 Cyclobenzaprine Hydrochloride 2 in 1 BOTTLE TABLET, FILM COATED 2 1 76420-269-07 Cyclobenzaprine Hydrochloride 7 in 1 BOTTLE TABLET, FILM COATED 7 1 76420-269-10 Cyclobenzaprine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 1 76420-269-15 Cyclobenzaprine Hydrochloride 15 in 1 BOTTLE TABLET, FILM COATED 15 1 76420-269-20 Cyclobenzaprine Hydrochloride 20 in 1 BOTTLE TABLET, FILM COATED 20 1 76420-269-30 Cyclobenzaprine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 1 76420-269-60 Cyclobenzaprine Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 1 76420-269-90 Cyclobenzaprine Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-269 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.] 1 Current NDC, Legacy NDC, 9 package rows 20220908_f8dec4e2-3151-4a79-b194-a11a57ada0b6.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 · 3 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 76420-269-02 76420026902 2 TABLET, FILM COATED in 1 BOTTLE (76420-269-02) 2022-09-03 0000-00-00 No No Current