Cyclobenzaprine Hydrochloride

Product NDC
51655-973
11-digit product format
516550973
Labeler code
51655
Product ID
51655-973_4960a71d-10d7-6f03-e063-6394a90a710f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090478
Marketing category
ANDA
Marketing start
2022-05-04
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
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 · 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
2027-12-31

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
e04eea45-12ec-4d2b-e053-2a95a90a6b76Available 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
51655-973-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED203
51655-973-25Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603
51655-973-52Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
51655-973-53Cyclobenzaprine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103
51655-973-54Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED153
51655-973-87Cyclobenzaprine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-973CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 6 package rows20230404_e04eea45-12ec-4d2b-e053-2a95a90a6b76.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
ndc (product): 51655-973
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
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 TabletPSNe04eea45-12ec-4d2b-e053-2a95a90a6b763
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDe04eea45-12ec-4d2b-e053-2a95a90a6b763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-973-205165509732020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-20) 2022-10-17NoNoCurrent
51655-973-255165509732560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-25) 2022-09-06NoNoCurrent
51655-973-525165509735230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-52) 2022-10-07NoNoCurrent
51655-973-535165509735310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-53) 2022-07-27NoNoCurrent
51655-973-545165509735415 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-54) 2022-08-24NoNoCurrent
51655-973-87516550973876 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-87) 2022-05-040000-00-00NoNoCurrent