Cyclobenzaprine Hydrochloride

Product NDC
63187-923
11-digit product format
631870923
Labeler code
63187
Product ID
63187-923_7e7dea0f-3605-4fe0-b204-d46938a16a6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078722
Marketing category
ANDA
Marketing start
2017-08-01
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-923DDiscontinued by firm2026-08-07
excluded packagepackage63187-92363187-923-30DDiscontinued by firm2026-08-07
excluded packagepackage63187-92363187-923-60DDiscontinued by firm2026-08-07
excluded packagepackage63187-92363187-923-72DDiscontinued by firm2026-08-07
excluded packagepackage63187-92363187-923-78DDiscontinued by firm2026-08-07
excluded packagepackage63187-92363187-923-90DDiscontinued by firm2026-08-07

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-923-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-923-78d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-923-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-923-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-923-72d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-923-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-923-78f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-923-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-923-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-923-72f5e01cc5f278…a2eaf40c39c3…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-923-30EA - Each63187-92317650795-ae51-439f-b682-1ddfec48625912018-05-09
63187-923-60EA - Each63187-923a13a849c-794d-4e56-8eff-6111f414551412017-12-14
63187-923-72EA - Each63187-92300b73add-d57f-4f14-8f03-a6f5a6efb01012018-05-09
63187-923-90EA - Each63187-92390a6fb5c-32c1-47fa-8a98-5f1ce91a317412017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-923CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2Legacy NDC20191108_258db60a-d33d-4da2-ad16-927f6b26c58d.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
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.07e3ec53-f1f2-4231-aec6-1772a146ba882024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078722
application number: ANDA078722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-923-306318709233030 TABLET, FILM COATED in 1 BOTTLE (63187-923-30) 2017-10-020000-00-00NoNoCurrent
63187-923-606318709236060 TABLET, FILM COATED in 1 BOTTLE (63187-923-60) 2017-10-020000-00-00NoNoCurrent
63187-923-7263187092372120 TABLET, FILM COATED in 1 BOTTLE (63187-923-72) 2017-10-020000-00-00NoNoCurrent
63187-923-7863187092378180 TABLET, FILM COATED in 1 BOTTLE (63187-923-78) 2017-10-020000-00-00NoNoCurrent
63187-923-906318709239090 TABLET, FILM COATED in 1 BOTTLE (63187-923-90) 2017-10-020000-00-00NoNoCurrent