CYCLOBENZAPRINE HCI

Product NDC
61919-681
Requested package NDC
61919-681-72
11-digit product format
619190681
Labeler code
61919
Product ID
61919-681_eada9db9-bce4-5ca9-e053-2a95a90a271c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HCI
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECTRX
Application
ANDA078722
Marketing category
ANDA
Marketing start
2019-04-02
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
2023-12-31
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 packagepackage61919-68161919-681-72IInactivated by FDA2026-08-07

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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 Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-681-30CYCLOBENZAPRINE HCI30 in 1 BOTTLETABLET, FILM COATED3012
61919-681-60CYCLOBENZAPRINE HCI60 in 1 BOTTLETABLET, FILM COATED6012
61919-681-72CYCLOBENZAPRINE HCI72 in 1 BOTTLETABLET, FILM COATED7212
61919-681-90CYCLOBENZAPRINE HCI90 in 1 BOTTLETABLET, FILM COATED9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-681-30EA - Each61919-681b60368c4-ffc4-43b3-8917-5123e448be0312021-11-09
61919-681-60EA - Each61919-681f7d91a82-32b7-4a87-ad00-9a7ce919fa6112022-10-06
61919-681-72EA - Each61919-6814cf999be-925a-4574-8da4-6b06fb49697812022-10-06
61919-681-90EA - Each61919-6811dc91934-f639-4c51-ba60-534f352bd92812019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-681CYCLOBENZAPRINE HCI TABLET, FILM COATED CYCLOBENZAPRINE HCL TABLET, FILM COATED [DIRECTRX]12Legacy NDC, 4 package rows20230608_858d10e7-dfe5-4c4f-e053-2a91aa0a783e.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN858d10e7-dfe5-4c4f-e053-2a91aa0a783e12
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN858d10e7-dfe5-4c4f-e053-2a91aa0a783e12
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD858d10e7-dfe5-4c4f-e053-2a91aa0a783e12
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD858d10e7-dfe5-4c4f-e053-2a91aa0a783e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-681-726191906817272 TABLET, FILM COATED in 1 BOTTLE (61919-681-72) 2019-04-020000-00-00NoNoCurrent