Cyclobenzaprine Hydrochloride

Product NDC
76420-271
Requested package NDC
76420-271-20
11-digit product format
764200271
Labeler code
76420
Product ID
76420-271_e7bfa09d-7e18-d2bf-e053-2995a90a9145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA071611
Marketing category
ANDA
Marketing start
2021-07-20
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071611-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03
A071611-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03
A071611-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071611-001AB
A071611-002AB
A071611-003AB

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 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 UTC2026-02A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-038072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071611-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071611-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071611-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071611-001AB18072bd15b7f6…

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828299Internal RxNorm lookup
828320Internal RxNorm lookup
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
f8dec4e2-3151-4a79-b194-a11a57ada0b6Available 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
76420-271-01Cyclobenzaprine Hydrochloride1 in 1 BOTTLETABLET, FILM COATED11
76420-271-02Cyclobenzaprine Hydrochloride2 in 1 BOTTLETABLET, FILM COATED21
76420-271-07Cyclobenzaprine Hydrochloride7 in 1 BOTTLETABLET, FILM COATED71
76420-271-10Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
76420-271-12Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1201
76420-271-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151
76420-271-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED201
76420-271-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
76420-271-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
76420-271-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-271-01EA - Each76420-271902e8c15-b7a0-4512-87c8-64cfcea0df8912022-10-06
76420-271-02EA - Each76420-2718fd2ca8a-f96b-4063-a1ee-90138317e9e812022-10-06
76420-271-07EA - Each76420-2719b754527-6cad-49df-ad45-459436ae815b12022-10-06
76420-271-10EA - Each76420-27185a1486a-7040-46c4-89d8-f25e43647c2212022-10-06
76420-271-12EA - Each76420-27132b32570-6463-446e-9471-4676e449c1da12022-10-06
76420-271-15EA - Each76420-2715807a101-e1b7-4472-b1f1-78472b68202812022-10-06
76420-271-20EA - Each76420-2713eb962ae-a583-41b4-98af-26c384e4ad2212022-10-06
76420-271-30EA - Each76420-2712f635c6d-6261-42f2-a6e7-16564c1562e112022-10-06
76420-271-60EA - Each76420-2712e71de15-377b-4073-886a-c2e63d1318e912022-10-06
76420-271-90EA - Each76420-2717f011287-3ed9-44ad-a6f8-146549bdb5d212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-271CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 10 package rows20220908_f8dec4e2-3151-4a79-b194-a11a57ada0b6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.1d9e34cc-eee9-4147-abf8-c810a80e39d22026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071611
application number: ANDA071611
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1ac77323-7526-a129-e063-6394a90a641b2024-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071611
application number: ANDA071611
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.f8dec4e2-3151-4a79-b194-a11a57ada0b62022-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071611
application number: ANDA071611
ndc (package): 76420-271-20
ndc (product): 76420-271
ndc11 (package): 76420027120

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf8dec4e2-3151-4a79-b194-a11a57ada0b61
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf8dec4e2-3151-4a79-b194-a11a57ada0b61
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNf8dec4e2-3151-4a79-b194-a11a57ada0b61
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf8dec4e2-3151-4a79-b194-a11a57ada0b61
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf8dec4e2-3151-4a79-b194-a11a57ada0b61
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDf8dec4e2-3151-4a79-b194-a11a57ada0b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-271-207642002712020 TABLET, FILM COATED in 1 BOTTLE (76420-271-20) 2022-09-030000-00-00NoNoCurrent