Cyclobenzaprine Hydrochloride

Product NDC
55154-8143
Requested package NDC
55154-8143-0
11-digit product format
551548143
Labeler code
55154
Product ID
55154-8143_6f6db226-c5a8-4a9e-b31c-0d6113a59b9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health
Application
ANDA077797
Marketing category
ANDA
Marketing start
2007-02-28
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55154-814355154-8143-0DDiscontinued by firm2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8143-05515481430010 BLISTER PACK in 1 BAG (55154-8143-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2007-02-280000-00-00NoNoCurrent