Cyclobenzaprine Hydrochloride

Product NDC
71335-0096
11-digit product format
713350096
Labeler code
71335
Product ID
71335-0096_74ade2d7-286b-45e1-ad98-19c4235d4c7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078722-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2008-05-12
A078722-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2008-05-12
A078722-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL2008-05-12

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2008-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2008-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL2008-05-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2008-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2008-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL2008-05-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078722-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2008-05-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078722-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2008-05-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078722-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2008-05-128072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A078722-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078722-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078722-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078722-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078722-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078722-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078722-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078722-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078722-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078722-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078722-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078722-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078722-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078722-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078722-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078722-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078722-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078722-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078722-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078722-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078722-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078722-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078722-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078722-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078722-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078722-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078722-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078722-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078722-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078722-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078722-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078722-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078722-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078722-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078722-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078722-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078722-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078722-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078722-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078722-001AB15d02ea3f76ae…

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0VE05JYS2PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828299Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59f31ca3-1b28-4768-bb29-520f06f4a9f5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0096-0Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED1011
71335-0096-1Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6011
71335-0096-2Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
71335-0096-3Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9011
71335-0096-4Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED12011
71335-0096-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED1511
71335-0096-6Cyclobenzaprine Hydrochloride45 in 1 BOTTLETABLET, FILM COATED4511
71335-0096-7Cyclobenzaprine Hydrochloride9 in 1 BOTTLETABLET, FILM COATED911
71335-0096-8Cyclobenzaprine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED18011
71335-0096-9Cyclobenzaprine Hydrochloride14 in 1 BOTTLETABLET, FILM COATED1411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0096-1EA - Each71335-0096ca937206-2159-433c-8227-a65fc8daf4ab12018-04-19
71335-0096-2EA - Each71335-0096dd441c02-40fc-4e32-80d3-8c46794b3dc212018-05-09
71335-0096-3EA - Each71335-0096c1674327-6287-4a7b-856d-cc0f46f475d812018-04-19
71335-0096-4EA - Each71335-00961196792a-e710-4fbc-b7cc-91b47edaece012018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0096CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 10 package rows20240821_59f31ca3-1b28-4768-bb29-520f06f4a9f5.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPae3a3f5c-fb64-4a43-be88-a2fc7c298ac12026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078722
application number: ANDA078722
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.a4cc7965-2ba8-42e8-8c5c-b90145a6598a2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078722
application number: ANDA078722
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLPHOENIX RX LLC3a397e88-d267-feed-e063-6294a90a77102026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078722
application number: ANDA078722
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions81917fa4-c79c-46e2-bfbb-507fc0d7ed1b2025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078722
application number: ANDA078722
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESA3, LLCa4ae481f-9e47-470a-b4d1-5a33c0df87612025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078722
application number: ANDA078722
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCb062cb80-79a9-c5d8-e053-2a95a90aecfc2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078722
application number: ANDA078722
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEQuality Care Products LLC794d350b-6c88-41d5-b68b-3e2c57ee2a4f2024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078722
application number: ANDA078722
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack59f31ca3-1b28-4768-bb29-520f06f4a9f52024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078722
application number: ANDA078722
ndc (product): 71335-0096
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.07e3ec53-f1f2-4231-aec6-1772a146ba882024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078722
application number: ANDA078722

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN59f31ca3-1b28-4768-bb29-520f06f4a9f511
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD59f31ca3-1b28-4768-bb29-520f06f4a9f511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0096-07133500960010 TABLET, FILM COATED in 1 BOTTLE (71335-0096-0) 2022-03-090000-00-00NoNoCurrent
71335-0096-17133500960160 TABLET, FILM COATED in 1 BOTTLE (71335-0096-1) 2018-03-200000-00-00NoNoCurrent
71335-0096-27133500960230 TABLET, FILM COATED in 1 BOTTLE (71335-0096-2) 2018-03-050000-00-00NoNoCurrent
71335-0096-37133500960390 TABLET, FILM COATED in 1 BOTTLE (71335-0096-3) 2018-03-200000-00-00NoNoCurrent
71335-0096-471335009604120 TABLET, FILM COATED in 1 BOTTLE (71335-0096-4) 2018-05-090000-00-00NoNoCurrent
71335-0096-57133500960515 TABLET, FILM COATED in 1 BOTTLE (71335-0096-5) 2019-09-270000-00-00NoNoCurrent
71335-0096-67133500960645 TABLET, FILM COATED in 1 BOTTLE (71335-0096-6) 2022-03-090000-00-00NoNoCurrent
71335-0096-7713350096079 TABLET, FILM COATED in 1 BOTTLE (71335-0096-7) 2018-09-040000-00-00NoNoCurrent
71335-0096-871335009608180 TABLET, FILM COATED in 1 BOTTLE (71335-0096-8) 2022-03-090000-00-00NoNoCurrent
71335-0096-97133500960914 TABLET, FILM COATED in 1 BOTTLE (71335-0096-9) 2018-04-230000-00-00NoNoCurrent