FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
50090-5756
11-digit product format
500905756
Labeler code
50090
Product ID
50090-5756_1882fcff-f03c-4c72-9202-397e9643c330
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213324
Marketing category
ANDA
Marketing start
2020-07-06
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
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 44.

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
A213324-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-06
A213324-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-06
A213324-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213324-001AB
A213324-002AB
A213324-003AB

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.

Product history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-06c2088c7a36db…
2026-10-15 13:18:302026-09A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-06c2088c7a36db…
2026-10-15 13:18:302026-09A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-05c2088c7a36db…
2026-09-14 22:38:342026-08A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-0584e616aacf4f…
2026-08-18 06:07:402026-07A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A213324-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2020-07-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A213324-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-07-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213324-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-07-0679d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A213324-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A213324-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A213324-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A213324-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213324-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213324-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A213324-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213324-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213324-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213324-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213324-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213324-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213324-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213324-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213324-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213324-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213324-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213324-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213324-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213324-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213324-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213324-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213324-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213324-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213324-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213324-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213324-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213324-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213324-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213324-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213324-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213324-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213324-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213324-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213324-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213324-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213324-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213324-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213324-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213324-001AB179d66fd596c7…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5756-02023-02-06Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-02023-02-06Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-12023-02-06Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-12023-02-06Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-22023-02-06Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-22023-02-06Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-32023-02-06Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-32023-02-06Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-02023-01-30Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-02023-01-30Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-12023-01-30Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-12023-01-30Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-22023-01-30Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-22023-01-30Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-32023-01-30Cyclobenzaprine hydrochloride Tablets, USP
50090-5756-32023-01-30Cyclobenzaprine hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5756-0Cyclobenzaprine hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
50090-5756-1Cyclobenzaprine hydrochloride20 in 1 BOTTLETABLET, FILM COATED2011
50090-5756-2Cyclobenzaprine hydrochloride90 in 1 BOTTLETABLET, FILM COATED9011
50090-5756-3Cyclobenzaprine hydrochloride24 in 1 BOTTLETABLET, FILM COATED2411
50090-5756-4Cyclobenzaprine hydrochloride10 in 1 BOTTLETABLET, FILM COATED1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5756-0EA - Each50090-5756dae20783-278e-4818-a197-b6e54a3d868612022-10-06
50090-5756-1EA - Each50090-5756dac2e6f9-9bc1-4cdb-b369-a4518a32498212022-10-06
50090-5756-2EA - Each50090-57566032e659-812a-41ba-8567-c92e7a2d5bae12022-10-06
50090-5756-3EA - Each50090-575695dfc9c2-78c5-41a1-9e5d-0d884bcce59612022-10-06
50090-5756-4EA - Each50090-57566a005bce-dcaf-4f74-abfc-378c8bd4cf9712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5756CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 5 package rows20240530_f2286776-a7de-42dc-b745-d250e741eeb6.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack4a2d3cae-5c64-4986-9707-cc213b70b7ad2023-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213324
application number: ANDA213324
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack6ebaccfc-f57c-4547-ade0-6a6e204f5ea02023-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213324
application number: ANDA213324
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.1adcdd8a-30f9-4a7b-853c-948a5589acab2023-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213324
application number: ANDA213324
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.59945ea1-8136-4014-acd9-cdfe6e11e8da2022-07-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213324
application number: ANDA213324

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf2286776-a7de-42dc-b745-d250e741eeb611
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf2286776-a7de-42dc-b745-d250e741eeb611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5756-05009057560030 TABLET, FILM COATED in 1 BOTTLE (50090-5756-0) 2021-10-010000-00-00NoNoCurrent
50090-5756-15009057560120 TABLET, FILM COATED in 1 BOTTLE (50090-5756-1) 2021-10-010000-00-00NoNoCurrent
50090-5756-25009057560290 TABLET, FILM COATED in 1 BOTTLE (50090-5756-2) 2021-10-010000-00-00NoNoCurrent
50090-5756-35009057560324 TABLET, FILM COATED in 1 BOTTLE (50090-5756-3) 2021-11-010000-00-00NoNoCurrent
50090-5756-45009057560410 TABLET, FILM COATED in 1 BOTTLE (50090-5756-4) 2024-05-17NoNoCurrent
50090-5756-5500905756057 TABLET, FILM COATED in 1 BOTTLE (50090-5756-5) 2026-09-22NoNoCurrent