Cyclobenzaprine Hydrochloride

Product NDC
70512-872
11-digit product format
705120872
Labeler code
70512
Product ID
70512-872_3b2ac0d1-9247-b044-e063-6294a90a6780
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SOLA Pharmaceuticals, LLC
Application
ANDA077563
Marketing category
ANDA
Marketing start
2025-07-31
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
A077563-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19
A077563-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19
A077563-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077563-001AB
A077563-002AB
A077563-003AB

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 UTC2026-02A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-198072bd15b7f6…

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 UTC2026-02A077563-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077563-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077563-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077563-001AB18072bd15b7f6…

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 · 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
db930d05-3f92-41f1-888c-301b2c4565e6Available 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
70512-872-10Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-872-10EA - Each70512-872d0798262-1631-411c-bf86-19ec3b8ec97f12025-09-12

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.84be93c5-1526-465e-ab0b-c6d10ba1521d2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLDirect_Rx55683c5c-0f86-9a26-e063-6294a90a8e8c2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDECoupler LLC47d22c6d-49fb-f97c-e063-6294a90a6ba12026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEDoc Rx4c054230-1978-44d2-9467-ed19946191132025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC3bddfe25-00ba-747f-e063-6394a90a9ce62025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESOLA Pharmaceuticals, LLCdb930d05-3f92-41f1-888c-301b2c4565e62025-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
ndc (product): 70512-872
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAvKAREa264ab9f-cc12-325f-e053-2a95a90a53d92025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC34f4e63a-1259-0226-e063-6294a90a9fc42025-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack3f1b9c8a-8f75-4b84-af0c-739815937fd72025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackdcef9b63-f998-4852-920d-c356623cea6a2025-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.592871f6-0eb2-4624-9e10-bd8bf767c0022025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCafca2a49-6424-7b6a-e053-2a95a90ad41e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNdb930d05-3f92-41f1-888c-301b2c4565e62
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDdb930d05-3f92-41f1-888c-301b2c4565e62
828348cyclobenzaprine HCl 10 MG Oral TabletPSN3bddfe25-00ba-747f-e063-6394a90a9ce61
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4c054230-1978-44d2-9467-ed19946191131
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD3bddfe25-00ba-747f-e063-6394a90a9ce61
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4c054230-1978-44d2-9467-ed19946191131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70512-872-1070512087210100 TABLET, FILM COATED in 1 BOTTLE (70512-872-10) 2025-07-31NoNoCurrent