Home NDC 53489-591 Cyclobenzaprine Hydrochloride
Product NDC 53489-591
11-digit product format 534890591
Labeler code 53489
Product ID 53489-591_f31e2835-b272-4f87-bbc7-6cb4ec25fde9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mutual Pharmaceutical
Application ANDA073541
Marketing category ANDA
Marketing start 1995-05-23
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 E
Listing certified through 2017-12-31
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 3 · 132 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 53489-591-01 Cyclobenzaprine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 4 53489-591-05 Cyclobenzaprine Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 4 53489-591-07 Cyclobenzaprine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 4 53489-591-10 Cyclobenzaprine Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4 53489-591-60 Cyclobenzaprine Hydrochloride 20 in 1 BOTTLE TABLET, FILM COATED 20 4
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 [MUTUAL PHARMACEUTICAL] 4 Cyclobenzaprine ACTIVE MOIETY 69O5WQQ5TI CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] 4 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] 4 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] 4 lactose INACTIVE INGREDIENT J2B2A4N98G CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] 4 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] 4 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] 4 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] 4 starch, corn INACTIVE INGREDIENT O8232NY3SJ CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] 4 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 53489-591 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] 4 Legacy NDC, 5 package rows 20130514_ac490da0-6347-4f5d-bcae-c23261b43725.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53489-591-01 53489059101 100 in 1 BOTTLE Historical 53489-591-05 53489059105 500 in 1 BOTTLE Historical 53489-591-07 53489059107 30 in 1 BOTTLE Historical 53489-591-10 53489059110 1000 in 1 BOTTLE Historical 53489-591-60 53489059160 20 in 1 BOTTLE Historical