Cyclobenzaprine Hydrochloride

Product NDC
71205-201
11-digit product format
712050201
Labeler code
71205
Product ID
71205-201_9143ab9f-5bc2-4ea6-a33b-01bbc1e880f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077797
Marketing category
ANDA
Marketing start
2017-03-30
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077797-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28
A077797-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077797-001AB
A077797-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077797-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077797-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077797-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077797-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077797-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077797-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077797-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077797-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077797-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077797-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077797-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077797-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077797-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077797-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077797-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077797-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077797-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077797-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077797-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077797-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077797-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077797-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077797-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077797-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077797-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077797-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077797-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077797-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077797-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077797-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077797-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077797-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077797-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077797-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077797-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077797-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077797-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077797-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077797-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077797-002AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 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
828348Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
571fbb2b-24e0-4de3-8cfa-c267fc397b6cAvailable 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
71205-201-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED102
71205-201-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152
71205-201-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
71205-201-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
71205-201-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
71205-201-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-201CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20191012_571fbb2b-24e0-4de3-8cfa-c267fc397b6c.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEGolden State Medical Supply, Inc.15c0c7aa-8c54-4040-a1bf-2a7b421ad33f2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.59b428fa-5013-4b2b-872f-16ba4a9d4f5d2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9161cb5e-63e5-41d7-9bde-66c7b7b7a2f32025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3aaa4808-7f2d-410c-9b6c-193549ec08452025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7829a96a-3668-4d88-90e9-0ecbedb2bd7e2025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3baeda95-d098-437a-b360-87a9c3f3fd9b2025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackaa29e260-fb77-415a-a505-3230d30c89452025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLCafcad582-ab59-4f70-e053-2a95a90a04e42024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack4c51f56b-33c3-4611-bba8-876d9dde7aff2024-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack90c7a982-6442-4241-a60b-b5dfab2abb712024-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackc86303a0-7c8b-415e-acac-1070b7d0d4452024-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.68db3c3b-8da1-4852-90b0-3172f842aa022023-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESolco Healthcare U.S., LLCf558863b-ea3f-4e4b-85e9-edb2573e71512022-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCbe5201bc-e1f1-41af-be46-4a8fbb223b862020-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LP571fbb2b-24e0-4de3-8cfa-c267fc397b6c2019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
ndc (product): 71205-201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN571fbb2b-24e0-4de3-8cfa-c267fc397b6c2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD571fbb2b-24e0-4de3-8cfa-c267fc397b6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-201-107120502011010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-10) 2019-01-010000-00-00NoNoCurrent
71205-201-157120502011515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-15) 2019-01-010000-00-00NoNoCurrent
71205-201-207120502012020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-20) 2019-01-010000-00-00NoNoCurrent
71205-201-307120502013030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-30) 2019-01-010000-00-00NoNoCurrent
71205-201-607120502016060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-60) 2019-01-010000-00-00NoNoCurrent
71205-201-907120502019090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-90) 2019-01-010000-00-00NoNoCurrent