Home NDC 53808-0862 Cyclobenzaprine Hydrochloride
Product NDC 53808-0862
11-digit product format 538080862
Labeler code 53808
Product ID 53808-0862_9fc869dc-7e21-43b0-8170-e25bb74365f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA073541
Marketing category ANDA
Marketing start 2013-01-01
Marketing end 0000-00-00
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 2019-12-31
Current FDA listing Historical FDA.report record 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 · 42 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0862-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0862-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-0862-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-0862-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-0862-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0862-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0862-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0862-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0862-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0862-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0862-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0862-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0862-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0862-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0862-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0862-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0862-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0862-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0862-1 8dfbde2a14a4…c9ff85d89658…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 53808-0862-1 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 53808-0862-1 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 82 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 2026-02-19 14:30 UTC 2026-02 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073541-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1995-05-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A073541-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-04-06 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 53808-0862-1 Cyclobenzaprine Hydrochloride 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
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 [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Cyclobenzaprine ACTIVE MOIETY 69O5WQQ5TI CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0862 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20140404_ab3f3674-e0ee-473c-9e07-4a836f0603b6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0862-1 53808086201 30 in 1 BLISTER PACK Historical