FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
71335-2666
11-digit product format
713352666
Labeler code
71335
Product ID
71335-2666_71c2dd8a-818a-444b-bdfb-9f8b6bc55f3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA218936
Marketing category
ANDA
Marketing start
2025-02-19
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 43.

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
A218936-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-12
A218936-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-12
A218936-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A218936-001AB
A218936-002AB
A218936-003AB

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
2026-09-14 22:38:342026-08A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-1284e616aacf4f…
2026-09-14 22:38:342026-08A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-1284e616aacf4f…
2026-09-14 22:38:342026-08A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-1284e616aacf4f…
2026-08-18 06:07:402026-07A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-122680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-12d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218936-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2024-09-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218936-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2024-09-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218936-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2024-09-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218936-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218936-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A218936-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A218936-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218936-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218936-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218936-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218936-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218936-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218936-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218936-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218936-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218936-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218936-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218936-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218936-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218936-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218936-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218936-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218936-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218936-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218936-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218936-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218936-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218936-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218936-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218936-003AB12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218936-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218936-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218936-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218936-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A218936-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A218936-003AB1d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218936-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218936-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218936-003AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
6536b470-9a4e-4174-85b8-479f64cc3296Available 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
71335-2666-0Cyclobenzaprine Hydrochloride40 in 1 BOTTLETABLET401
71335-2666-1Cyclobenzaprine Hydrochloride14 in 1 BOTTLETABLET141
71335-2666-2Cyclobenzaprine Hydrochloride84 in 1 BOTTLETABLET841
71335-2666-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET301
71335-2666-4Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET201
71335-2666-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET151
71335-2666-6Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET601
71335-2666-7Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET901
71335-2666-8Cyclobenzaprine Hydrochloride56 in 1 BOTTLETABLET561
71335-2666-9Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2666-0EA - Each71335-2666d0af36e4-8e05-4d6a-8ec5-474ab56f938d12025-10-14
71335-2666-1EA - Each71335-26665da9b6fe-7654-4bed-ac77-c7dc00e56e9912025-09-12
71335-2666-3EA - Each71335-26668febe56c-21c2-4750-8ee1-d764b161520012025-09-12
71335-2666-4EA - Each71335-266604552fcd-e4cb-4120-97ad-f5d3aa721a8612025-09-12
71335-2666-5EA - Each71335-2666d0ca3f45-c368-496a-a18a-5619ae765fef12025-09-12
71335-2666-6EA - Each71335-26661410ac77-7eb8-4b8b-ada4-7214eb417a6f12025-09-12
71335-2666-7EA - Each71335-2666d5868410-9637-4ac8-8ab9-fbc52b6e634a12025-09-12
71335-2666-9EA - Each71335-2666cfc516f1-8032-4121-a530-6df816df491e12025-09-12

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.34e57aff-dc4b-4631-9d57-31020244835d2026-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218936
application number: ANDA218936
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack6536b470-9a4e-4174-85b8-479f64cc32962025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218936
application number: ANDA218936
ndc (product): 71335-2666
FexmidCYCLOBENZAPRINE HYDROCHLORIDERising Pharma Holdings, Inc.41838966-de0b-4855-83b8-2ff6c764ed1f2025-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218936
application number: ANDA218936
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDERising Pharma Holdings, Inc.6018b6e9-938d-4fc9-86d7-1fd1d7bfcc582025-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218936
application number: ANDA218936

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN6536b470-9a4e-4174-85b8-479f64cc32961
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD6536b470-9a4e-4174-85b8-479f64cc32961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2666-07133526660040 TABLET in 1 BOTTLE (71335-2666-0) 40 tablet2025-07-14NoNoCurrent
71335-2666-17133526660114 TABLET in 1 BOTTLE (71335-2666-1) 14 tablet2025-07-14NoNoCurrent
71335-2666-27133526660284 TABLET in 1 BOTTLE (71335-2666-2) 84 tablet2025-07-14NoNoCurrent
71335-2666-37133526660330 TABLET in 1 BOTTLE (71335-2666-3) 30 tablet2025-07-14NoNoCurrent
71335-2666-47133526660420 TABLET in 1 BOTTLE (71335-2666-4) 20 tablet2025-07-14NoNoCurrent
71335-2666-57133526660515 TABLET in 1 BOTTLE (71335-2666-5) 15 tablet2025-07-14NoNoCurrent
71335-2666-67133526660660 TABLET in 1 BOTTLE (71335-2666-6) 60 tablet2025-07-14NoNoCurrent
71335-2666-77133526660790 TABLET in 1 BOTTLE (71335-2666-7) 90 tablet2025-07-14NoNoCurrent
71335-2666-87133526660856 TABLET in 1 BOTTLE (71335-2666-8) 56 tablet2025-07-14NoNoCurrent
71335-2666-971335266609120 TABLET in 1 BOTTLE (71335-2666-9) 120 tablet2025-07-14NoNoCurrent