Cyclobenzaprine Hydrochloride

Product NDC
76420-010
11-digit product format
764200010
Labeler code
76420
Product ID
76420-010_17d7186f-a791-93d2-e063-6294a90ac7d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA078722
Marketing category
ANDA
Marketing start
2017-09-28
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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 · 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE7.5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828299Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
07e3ec53-f1f2-4231-aec6-1772a146ba88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-010-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
76420-010-05Cyclobenzaprine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5004
76420-010-12Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1204
76420-010-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED154
76420-010-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
76420-010-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
76420-010-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-010-01EA - Each76420-01066eafb92-9919-4470-b286-658683965dc112022-12-07
76420-010-05EA - Each76420-01044524994-a810-4b38-9135-58f0db6548a712022-12-07
76420-010-15EA - Each76420-0100bdcbb18-431a-46ce-aefa-af585661ff6b12022-12-07
76420-010-30EA - Each76420-01058796f92-a2e5-4881-ac6b-32293635a0e612022-12-07
76420-010-60EA - Each76420-010da512150-95b6-4cc8-9988-327b32399fe312022-12-07
76420-010-90EA - Each76420-01047c93814-21fa-4439-bfc1-3df8fe4c0cb912022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-010CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.]4Current NDC, Legacy NDC, 7 package rows20240508_07e3ec53-f1f2-4231-aec6-1772a146ba88.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
ndc (product): 76420-010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN07e3ec53-f1f2-4231-aec6-1772a146ba884
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD07e3ec53-f1f2-4231-aec6-1772a146ba884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-010-0176420001001100 TABLET, FILM COATED in 1 BOTTLE (76420-010-01) 2022-10-210000-00-00NoNoCurrent
76420-010-0576420001005500 TABLET, FILM COATED in 1 BOTTLE (76420-010-05) 2022-10-210000-00-00NoNoCurrent
76420-010-1276420001012120 TABLET, FILM COATED in 1 BOTTLE (76420-010-12) 2023-03-16NoNoCurrent
76420-010-157642000101515 TABLET, FILM COATED in 1 BOTTLE (76420-010-15) 2022-10-210000-00-00NoNoCurrent
76420-010-307642000103030 TABLET, FILM COATED in 1 BOTTLE (76420-010-30) 2020-01-230000-00-00NoNoCurrent
76420-010-607642000106060 TABLET, FILM COATED in 1 BOTTLE (76420-010-60) 2020-01-230000-00-00NoNoCurrent
76420-010-907642000109090 TABLET, FILM COATED in 1 BOTTLE (76420-010-90) 2022-10-210000-00-00NoNoCurrent