Cyclobenzaprine Hydrochloride

Product NDC
60429-876
11-digit product format
604290876
Labeler code
60429
Product ID
60429-876_45b42f33-472c-dff2-e063-6394a90a379c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA077797
Marketing category
ANDA
Marketing start
2007-02-28
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

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-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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077797-001CYCLOBENZAPRINE 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…
2021-12-28 21:50 UTC2021-12A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A077797-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077797-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 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
828320Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
15c0c7aa-8c54-4040-a1bf-2a7b421ad33fAvailable 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
60429-876-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1007
60429-876-05Cyclobenzaprine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-876-01EA - Each60429-87650bacfca-8673-43d2-a632-9da65a3a4fb512017-09-11
60429-876-05EA - Each60429-87644110a84-fcaf-45f0-9a55-77bec781820c12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-876CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]6Current NDC, Legacy NDC, 2 package rows20240822_15c0c7aa-8c54-4040-a1bf-2a7b421ad33f.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
ndc (product): 60429-876
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN15c0c7aa-8c54-4040-a1bf-2a7b421ad33f7
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD15c0c7aa-8c54-4040-a1bf-2a7b421ad33f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-876-0160429087601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-876-01) 2017-04-070000-00-00NoNoCurrent
60429-876-0560429087605500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-876-05) 2017-04-070000-00-00NoNoCurrent