Home NDC 80425-0155 Cyclobenzaprine HCL
Product NDC 80425-0155
11-digit product format 804250155
Labeler code 80425
Product ID 80425-0155_2a99a7c1-c4c1-2b01-e063-6294a90aa3b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine HCL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA213324
Marketing category ANDA
Marketing start 2020-07-06
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 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05
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 3 · 117 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 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 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 HCL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 828320 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 80425-0155-1 Cyclobenzaprine HCL 30 in 1 BOTTLE TABLET, FILM COATED 30 9 80425-0155-2 Cyclobenzaprine HCL 60 in 1 BOTTLE TABLET, FILM COATED 60 9 80425-0155-3 Cyclobenzaprine HCL 90 in 1 BOTTLE TABLET, FILM COATED 90 9 80425-0155-4 Cyclobenzaprine HCL 120 in 1 BOTTLE TABLET, FILM COATED 120 9 80425-0155-5 Cyclobenzaprine HCL 180 in 1 BOTTLE TABLET, FILM COATED 180 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0155 CYCLOBENZAPRINE HCL TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 9 Current NDC, Legacy NDC, 5 package rows 20250101_c859f63a-09de-4eec-e053-2a95a90a312f.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 2 of 2 · 24 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 80425-0155-1 80425015501 30 TABLET, FILM COATED in 1 BOTTLE (80425-0155-1) 2023-03-30 No No Current 80425-0155-2 80425015502 60 TABLET, FILM COATED in 1 BOTTLE (80425-0155-2) 2023-03-30 No No Current 80425-0155-3 80425015503 90 TABLET, FILM COATED in 1 BOTTLE (80425-0155-3) 2023-03-30 No No Current 80425-0155-4 80425015504 120 TABLET, FILM COATED in 1 BOTTLE (80425-0155-4) 2023-03-30 No No Current 80425-0155-5 80425015505 180 TABLET, FILM COATED in 1 BOTTLE (80425-0155-5) 2023-03-30 No No Current