Home NDC 63187-157 Cyclobenzaprine Hydrochloride
Product NDC 63187-157
11-digit product format 631870157
Labeler code 63187
Product ID 63187-157_008d1180-1d6e-4ed2-950d-c494700dd7a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA078218
Marketing category ANDA
Marketing start 2010-02-18
Substance CYCLOBENZAPRINE HYDROCHLORIDE
Active strength 10 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
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 10 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 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 63187-157-10 Cyclobenzaprine Hydrochloride 10 in 1 BOTTLE TABLET, FILM COATED 10 4 63187-157-20 Cyclobenzaprine Hydrochloride 20 in 1 BOTTLE TABLET, FILM COATED 20 4 63187-157-30 Cyclobenzaprine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 4 63187-157-90 Cyclobenzaprine Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-157 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 4 Current NDC, Legacy NDC, 4 package rows 20191212_50aa421f-1d73-4b43-8528-2617ef2507dc.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 63187-157-10 63187015710 10 TABLET, FILM COATED in 1 BOTTLE (63187-157-10) 2014-09-01 0000-00-00 No No Current 63187-157-20 63187015720 20 TABLET, FILM COATED in 1 BOTTLE (63187-157-20) 2014-09-01 0000-00-00 No No Current 63187-157-30 63187015730 30 TABLET, FILM COATED in 1 BOTTLE (63187-157-30) 2014-09-01 0000-00-00 No No Current 63187-157-90 63187015790 90 TABLET, FILM COATED in 1 BOTTLE (63187-157-90) 2014-09-01 0000-00-00 No No Current