Cyclobenzaprine Hydrochloride

Product NDC
63187-590
11-digit product format
631870590
Labeler code
63187
Product ID
63187-590_dfd6a8bf-5460-47a3-9865-ec043cd9d17e
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
2015-03-25
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
2027-12-31
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
2027-12-31

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
ae3a3f5c-fb64-4a43-be88-a2fc7c298ac1Available 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
63187-590-09Cyclobenzaprine Hydrochloride9 in 1 BOTTLETABLET, FILM COATED96
63187-590-14Cyclobenzaprine Hydrochloride14 in 1 BOTTLETABLET, FILM COATED146
63187-590-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED206
63187-590-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
63187-590-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
63187-590-72Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1206
63187-590-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-590-14EA - Each63187-590f3d2393e-0602-4b01-bbd9-37414ad4ca5d12024-12-10
63187-590-20EA - Each63187-5907aacb400-c6b2-48cf-bb01-51edca9443e712024-10-04
63187-590-30EA - Each63187-5900d69d697-17ae-497d-9781-5e1836fbd68e12017-03-06
63187-590-60EA - Each63187-590c8d5b9d6-6b86-4532-9c27-adea55d4a76512016-04-04
63187-590-72EA - Each63187-590aa440d9c-cd69-4a54-a4be-0f832352dc6a12024-06-10
63187-590-90EA - Each63187-590e64edc88-3b42-4ee6-83ce-67e20dcc4d0d12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-590CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 7 package rows20240907_ae3a3f5c-fb64-4a43-be88-a2fc7c298ac1.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
ndc (product): 63187-590
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
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNae3a3f5c-fb64-4a43-be88-a2fc7c298ac16
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDae3a3f5c-fb64-4a43-be88-a2fc7c298ac16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-590-09631870590099 TABLET, FILM COATED in 1 BOTTLE (63187-590-09) 2026-05-13NoNoCurrent
63187-590-106318705901010 TABLET, FILM COATED in 1 BOTTLE (63187-590-10) 2018-12-010000-00-00NoNoCurrent
63187-590-146318705901414 TABLET, FILM COATED in 1 BOTTLE (63187-590-14) 2024-09-04NoNoCurrent
63187-590-156318705901515 TABLET, FILM COATED in 1 BOTTLE (63187-590-15) 2018-12-010000-00-00NoNoCurrent
63187-590-206318705902020 TABLET, FILM COATED in 1 BOTTLE (63187-590-20) 2018-12-010000-00-00NoNoCurrent
63187-590-216318705902121 TABLET, FILM COATED in 1 BOTTLE (63187-590-21) 2018-12-010000-00-00NoNoCurrent
63187-590-306318705903030 TABLET, FILM COATED in 1 BOTTLE (63187-590-30) 2018-12-010000-00-00NoNoCurrent
63187-590-456318705904545 TABLET, FILM COATED in 1 BOTTLE (63187-590-45) 2018-12-010000-00-00NoNoCurrent
63187-590-606318705906060 TABLET, FILM COATED in 1 BOTTLE (63187-590-60) 2018-12-010000-00-00NoNoCurrent
63187-590-7263187059072120 TABLET, FILM COATED in 1 BOTTLE (63187-590-72) 2018-12-010000-00-00NoNoCurrent
63187-590-7863187059078180 TABLET, FILM COATED in 1 BOTTLE (63187-590-78) 2018-12-010000-00-00NoNoCurrent
63187-590-906318705909090 TABLET, FILM COATED in 1 BOTTLE (63187-590-90) 2018-12-010000-00-00NoNoCurrent