FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
0378-0751
Requested package NDC
0378-0751-01
11-digit product format
003780751
Labeler code
0378
Product ID
0378-0751_30da9ca4-3bd1-4088-98ba-7e289ffc76be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA073144
Marketing category
ANDA
Marketing start
1991-05-30
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0378-07510378-0751-01DDiscontinued 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073144-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-30
A073144-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-03
A073144-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-25

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 UTC2026-02A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073144-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORAL2006-02-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073144-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORAL2013-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073144-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORAL1991-05-308072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A073144-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A073144-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A073144-003AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073144-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073144-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073144-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A073144-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A073144-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A073144-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073144-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A073144-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A073144-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073144-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A073144-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A073144-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073144-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A073144-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A073144-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A073144-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A073144-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A073144-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073144-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A073144-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A073144-003AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0751-01EA - Each0378-0751b3766038-d88d-467d-9923-a885cb81f00d12012-07-24
0378-0751-05EA - Each0378-0751f3c61b94-c9e3-4d22-8f2c-153c637c4e8e12012-07-24
0378-0751-10EA - Each0378-07515c1f13f0-e9cc-45fb-9995-0892c72035a912012-07-24
0378-0751-93EA - Each0378-0751c07031c7-4186-4b83-a76d-e6bd0667d45b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
TRIACETININACTIVE INGREDIENTXHX3C3X673CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0751-0100378075101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0751-01) 1991-05-300000-00-00NoNoCurrent