FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
10702-007
11-digit product format
107020007
Labeler code
10702
Product ID
10702-007_7d541fa9-d74b-5236-e053-2991aa0acc0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
KVK-TECH, Inc.
Application
ANDA078048
Marketing category
ANDA
Marketing start
2014-07-31
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
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
A078048-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2011-02-28
A078048-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2011-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078048-001AB
A078048-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078048-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2011-02-28a50c72e98297…
2026-08-01 22:54:322026-06A078048-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2011-02-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078048-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078048-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e505c31b-4618-4e4f-8da6-92030464004f2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078048
application number: ANDA078048
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAmerican Health Packaging5f321a03-ccfb-4c11-ac60-a461a5580c692024-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078048
application number: ANDA078048
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPf14bc532-e30f-490f-b97b-d0dab9a2ba0c2021-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078048
application number: ANDA078048
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCbb23383c-087a-4fb1-8917-edecd1ec45272020-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078048
application number: ANDA078048
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEKVK-TECH, Inc.5b756c04-e7b8-4efe-815a-3f3e020727fb2018-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078048
application number: ANDA078048
ndc (product): 10702-007

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828320Internal RxNorm lookup
828348Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b756c04-e7b8-4efe-815a-3f3e020727fbAvailable 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
10702-007-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1008
10702-007-03Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED308
10702-007-09Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED908
10702-007-10Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10008
10702-007-50Cyclobenzaprine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-007-01EA - Each10702-007fc51a639-855d-4fd0-8911-a0c47fcb923e12013-05-02
10702-007-03EA - Each10702-007288f969c-8f73-40ad-af74-b580d0fc0b8b12013-05-02
10702-007-09EA - Each10702-007528fa885-98e0-4155-b3c9-a19c2f3ba20712019-01-24
10702-007-10EA - Each10702-007803690ae-4de6-4584-b430-00a8881fe92912013-05-02
10702-007-50EA - Each10702-007614a0909-7455-4c4c-9f46-c0891d49b1df12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-007CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]8Current NDC, Legacy NDC, 5 package rows20181219_5b756c04-e7b8-4efe-815a-3f3e020727fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN5b756c04-e7b8-4efe-815a-3f3e020727fb8
828320cyclobenzaprine HCl 5 MG Oral TabletPSN5b756c04-e7b8-4efe-815a-3f3e020727fb8
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD5b756c04-e7b8-4efe-815a-3f3e020727fb8
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD5b756c04-e7b8-4efe-815a-3f3e020727fb8
828348cyclobenzaprine HCl 10 MG Oral TabletPSNbb23383c-087a-4fb1-8917-edecd1ec45273
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDbb23383c-087a-4fb1-8917-edecd1ec45273
828348cyclobenzaprine HCl 10 MG Oral TabletPSN5a409d46-bea2-1e76-e053-2a91aa0ac6261
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD5a409d46-bea2-1e76-e053-2a91aa0ac6261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10702-007-0110702000701100 TABLET, FILM COATED in 1 BOTTLE (10702-007-01) 2014-07-310000-00-00NoNoCurrent
10702-007-031070200070330 TABLET, FILM COATED in 1 BOTTLE (10702-007-03) 2014-07-310000-00-00NoNoCurrent
10702-007-091070200070990 TABLET, FILM COATED in 1 BOTTLE (10702-007-09) 2018-11-290000-00-00NoNoCurrent
10702-007-10107020007101000 TABLET, FILM COATED in 1 BOTTLE (10702-007-10) 2014-07-310000-00-00NoNoCurrent
10702-007-5010702000750500 TABLET, FILM COATED in 1 BOTTLE (10702-007-50) 2014-07-310000-00-00NoNoCurrent