Home NDC 65162-540 Cyclobenzaprine Hydrochloride
Product NDC 65162-540
11-digit product format 651620540
Labeler code 65162
Product ID 65162-540_df260758-80f8-4668-884c-7fb21600db2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals 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 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 65162-540-10 e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 65162-540-50 e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 65162-540-11 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65162-540-10 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65162-540-50 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65162-540-11 9bebd1f3094a…5416666fcb17…
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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65162-540-10 Cyclobenzaprine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 13 65162-540-11 Cyclobenzaprine Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 13 65162-540-50 Cyclobenzaprine Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CYCLOBENZAPRINE HYDROCHLORIDE ACTIVE INGREDIENT 0VE05JYS2P CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 CYCLOBENZAPRINE ACTIVE MOIETY 69O5WQQ5TI CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-540 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] 13 Current NDC, Legacy NDC, 3 package rows 20241027_390151d4-5fcb-46e2-92e6-de184827f43d.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 65162-540-10 65162054010 100 TABLET, FILM COATED in 1 BOTTLE (65162-540-10) 2010-02-18 0000-00-00 No No Current 65162-540-11 65162054011 1000 TABLET, FILM COATED in 1 BOTTLE (65162-540-11) 2010-02-18 0000-00-00 No No Current 65162-540-50 65162054050 500 TABLET, FILM COATED in 1 BOTTLE (65162-540-50) 2010-02-18 0000-00-00 No No Current