Cyclobenzaprine Hydrochloride

Product NDC
85509-1035
11-digit product format
855091035
Labeler code
85509
Product ID
85509-1035_48c33f75-b43a-b007-e063-6394a90a411e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA091281
Marketing category
ANDA
Marketing start
2019-03-01
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
15 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
A091281-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31
A091281-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091281-001AB
A091281-002AB

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 UTC2026-02A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091281-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A091281-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2013-01-31782e0a99824c…

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 UTC2026-02A091281-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091281-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091281-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091281-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091281-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091281-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091281-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091281-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091281-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091281-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091281-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091281-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091281-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091281-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091281-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091281-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091281-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091281-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091281-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091281-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091281-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091281-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091281-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091281-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091281-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091281-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091281-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091281-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091281-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091281-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091281-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091281-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091281-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091281-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091281-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091281-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091281-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091281-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091281-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091281-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE15 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
828358Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48c33e51-db07-af68-e063-6294a90a897eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1035-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
85509-1035-6Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
85509-1035-9Cyclobenzaprine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1035-3EA - Each85509-103589c49231-1e8c-485e-89d5-cf115cedfb7512026-02-05
85509-1035-6EA - Each85509-1035e52cfa42-920e-4c26-bc0c-488f4125a78212026-02-05
85509-1035-9EA - Each85509-10354e2b6df8-8d08-4735-8f5e-3373d0c6a7d012026-02-05

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 HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.550d3e5a-c95f-4094-a500-1a02ea35a18d2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.fada6577-bcb8-422c-be37-08562919ebc92026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPHOENIX RX LLC48c33e51-db07-af68-e063-6294a90a897e2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281
ndc (product): 85509-1035
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.ba659e1a-0091-45f6-b418-f4f36c9a2c792025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEUpsher-Smith Laboratories, LLC14f64ceb-ea5c-4d7c-a0c1-3f6a648472902025-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXa512d34c-8164-0c04-e053-2995a90a19422025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.3dd2bde1-f06d-493a-91c7-22b28a5e16992025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2998c9e6-2f60-ef35-e063-6394a90a7bc72024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackbfdd9460-5dfa-4588-8f4f-9d227c1717d52024-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPd8112916-28ae-452c-8ec8-a4972e5f549b2022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPffd82a69-a64c-4399-8f5d-bddc70cdc3cf2022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091281
application number: ANDA091281

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSN48c33e51-db07-af68-e063-6294a90a897e1
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCD48c33e51-db07-af68-e063-6294a90a897e1
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY48c33e51-db07-af68-e063-6294a90a897e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1035-38550910350330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-3) 2026-01-19NoNoCurrent
85509-1035-68550910350660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-6) 2026-01-19NoNoCurrent
85509-1035-98550910350990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-9) 2026-01-19NoNoCurrent