Cyclobenzaprine Hydrochloride

Product NDC
76282-283
11-digit product format
762820283
Labeler code
76282
Product ID
76282-283_19cb705f-c529-4ad4-8eda-3a3fd48feca7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET
Route
ORAL
Labeler
EXELAN PHARMACEUTICALS, INC.
Application
ANDA090478
Marketing category
ANDA
Marketing start
2025-04-10
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
A090478-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-23
A090478-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090478-001AB
A090478-002AB

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090478-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2010-07-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A090478-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2010-07-23782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090478-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090478-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090478-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090478-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090478-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090478-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090478-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090478-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090478-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090478-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090478-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090478-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090478-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090478-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090478-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090478-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090478-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090478-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090478-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090478-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090478-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090478-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090478-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090478-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090478-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090478-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090478-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090478-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090478-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090478-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090478-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090478-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090478-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090478-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090478-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090478-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090478-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090478-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090478-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090478-002AB1782e0a99824c…

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
cf81da00-7c6d-4477-bb70-b3c2abea177aAvailable 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
76282-283-10Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET10001
76282-283-18Cyclobenzaprine Hydrochloride180 in 1 BOTTLETABLET1801
76282-283-27Cyclobenzaprine Hydrochloride270 in 1 BOTTLETABLET2701
76282-283-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET301
76282-283-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET601
76282-283-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-283-10EA - Each76282-28332816277-5cb4-4870-bdec-757699b56c1412025-05-14
76282-283-18EA - Each76282-2837543a11a-fac4-4ed9-80e7-ddde22f3761a12025-05-14
76282-283-27EA - Each76282-28309093abc-352f-41d5-a8f1-9ece07e5622212025-05-14
76282-283-30EA - Each76282-283aebbf369-2a6a-498b-9f3d-5187522611dc12025-05-14
76282-283-60EA - Each76282-283a0b6ec51-a2ea-4135-8b3c-eec906fa13d312025-05-14
76282-283-90EA - Each76282-2834e14caff-1974-44c4-b140-5143491dd1d312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-283CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET [EXELAN PHARMACEUTICALS, INC.]1Current NDC, 6 package rows20250413_cf81da00-7c6d-4477-bb70-b3c2abea177a.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINECipla USA Inc.575a31fb-04c5-4001-88a7-c33adbacc6a82026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINENuCare Pharmaceuticals, Inc.4fbbc5b6-7aac-34e5-e054-00144ff88e882026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINENuCare Pharmaceuticals, Inc.4a2b5f25-a333-15f3-e054-00144ff8d46c2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINENorthwind Health Company, LLCe04eea45-12ec-4d2b-e053-2a95a90a6b762026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAmerican Health Packaging269bc278-963d-4830-816a-39bb4bf8c9362025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAvPAK64f6d1be-4067-a5c7-2343-4aed651a0cac2025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAvPAKe530fd1e-06fd-0432-e053-2995a90adf5f2025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAphena Pharma Solutions - Tennessee, LLC3bc7e2b4-e1a0-66e3-e063-6294a90a676a2025-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEEXELAN PHARMACEUTICALS, INC.cf81da00-7c6d-4477-bb70-b3c2abea177a2025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478
ndc (product): 76282-283
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINENCS HealthCare of KY, LLC dba Vangard Labs53688de9-2031-4d19-b422-4000285f7f472024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEProficient Rx LPae6de8d8-33c2-40bd-9dd3-782c879a9d8f2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090478
application number: ANDA090478

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN3bc7e2b4-e1a0-66e3-e063-6294a90a676a1
828348cyclobenzaprine HCl 10 MG Oral TabletPSNcf81da00-7c6d-4477-bb70-b3c2abea177a1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD3bc7e2b4-e1a0-66e3-e063-6294a90a676a1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDcf81da00-7c6d-4477-bb70-b3c2abea177a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-283-10762820283101000 TABLET in 1 BOTTLE (76282-283-10) 1000 tablet2025-04-10NoNoCurrent
76282-283-1876282028318180 TABLET in 1 BOTTLE (76282-283-18) 180 tablet2025-04-10NoNoCurrent
76282-283-2776282028327270 TABLET in 1 BOTTLE (76282-283-27) 270 tablet2025-04-10NoNoCurrent
76282-283-307628202833030 TABLET in 1 BOTTLE (76282-283-30) 30 tablet2025-04-10NoNoCurrent
76282-283-607628202836060 TABLET in 1 BOTTLE (76282-283-60) 60 tablet2025-04-10NoNoCurrent
76282-283-907628202839090 TABLET in 1 BOTTLE (76282-283-90) 90 tablet2025-04-10NoNoCurrent