Cyclobenzaprine Hydrochloride

Product NDC
0093-3422
11-digit product format
000933422
Labeler code
0093
Product ID
0093-3422_43707f11-5cf5-46a1-af67-c12153c11fd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals 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
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 · 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
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 · 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
1d9e34cc-eee9-4147-abf8-c810a80e39d2Available 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
0093-3422-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
0093-3422-05Cyclobenzaprine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5005
0093-3422-10Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3422-01EA - Each0093-34229d8c1297-5f7f-4a75-a77b-fd893e45a8ba12021-08-05
0093-3422-10EA - Each0093-34227632dec0-2100-4c0d-8019-faf88a21a75412021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3422CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]4Current NDC, Legacy NDC, 3 package rows20241127_1d9e34cc-eee9-4147-abf8-c810a80e39d2.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
ndc (product): 0093-3422
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN1d9e34cc-eee9-4147-abf8-c810a80e39d25
828320cyclobenzaprine HCl 5 MG Oral TabletPSN1d9e34cc-eee9-4147-abf8-c810a80e39d25
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN1d9e34cc-eee9-4147-abf8-c810a80e39d25
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD1d9e34cc-eee9-4147-abf8-c810a80e39d25
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD1d9e34cc-eee9-4147-abf8-c810a80e39d25
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD1d9e34cc-eee9-4147-abf8-c810a80e39d25
828348cyclobenzaprine HCl 10 MG Oral TabletPSN1ac77323-7526-a129-e063-6394a90a641b2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD1ac77323-7526-a129-e063-6394a90a641b2
828348cyclobenzaprine HCl 10 MG Oral TabletPSN51758c1e-aa26-4f41-8929-6041693257681
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf8dec4e2-3151-4a79-b194-a11a57ada0b61
828348cyclobenzaprine HCl 10 MG Oral TabletPSN89437fa6-cf30-49f7-89f3-bbc699ae28561
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4e763352-beb4-48d3-a08f-10edf01abc4a1
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 TabletSCD51758c1e-aa26-4f41-8929-6041693257681
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD89437fa6-cf30-49f7-89f3-bbc699ae28561
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4e763352-beb4-48d3-a08f-10edf01abc4a1
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
0093-3422-0100093342201100 TABLET, FILM COATED in 1 BOTTLE (0093-3422-01) 2021-07-200000-00-00NoNoCurrent
0093-3422-0500093342205500 TABLET, FILM COATED in 1 BOTTLE (0093-3422-05) 2021-07-200000-00-00NoNoCurrent
0093-3422-10000933422101000 TABLET, FILM COATED in 1 BOTTLE (0093-3422-10) 2021-07-200000-00-00NoNoCurrent