CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
87441-010
Requested package NDC
87441-010-01
11-digit product format
874410010
Labeler code
87441
Product ID
87441-010_53be0bcb-9f2d-ffda-e063-6294a90aac29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Solutions, Inc.
Application
ANDA208170
Marketing category
ANDA
Marketing start
2026-06-08
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]; Muscle Relaxant [EPC]
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
A208170-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-31
A208170-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-31
A208170-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALABRS2017-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208170-001AB
A208170-002AB
A208170-003AB

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 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALABRS2017-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALABRS2017-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALABRS2017-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2017-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALABRS2017-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALABRS2017-05-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-3187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-3187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALABRS2017-05-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-315aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-315aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALABRS2017-05-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-318869cabd3fbd…
2020-12-22 03:56 UTC2020-12A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-318869cabd3fbd…
2020-12-22 03:56 UTC2020-12A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALABRS2017-05-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-31c0c555d07b60…
2020-11-12 02:37 UTC2020-11A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-31c0c555d07b60…
2020-11-12 02:37 UTC2020-11A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALABRS2017-05-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-313f01610625f2…
2019-12-14 00:12 UTC2019-12A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-313f01610625f2…
2019-12-14 00:12 UTC2019-12A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2017-05-313f01610625f2…
2019-09-15 20:21 UTC2019-09A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-31b00525d2431f…
2019-09-15 20:21 UTC2019-09A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-31b00525d2431f…
2019-09-15 20:21 UTC2019-09A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2017-05-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-31ea99ee380514…
2019-07-19 19:46 UTC2019-07A208170-002CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-05-31ea99ee380514…
2019-07-19 19:46 UTC2019-07A208170-003CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2017-05-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208170-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-316a51e52b5d6a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208170-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208170-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208170-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208170-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208170-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208170-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208170-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208170-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208170-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208170-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208170-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208170-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208170-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208170-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208170-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208170-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208170-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208170-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208170-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208170-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208170-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208170-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208170-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208170-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208170-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A208170-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A208170-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208170-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A208170-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A208170-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208170-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A208170-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A208170-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208170-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A208170-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A208170-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208170-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A208170-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A208170-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208170-001AB16a51e52b5d6a…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.f2eb32c3-3da0-4938-9ed9-ea8420450fde2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETruPharma LLC08adc97f-feef-46fb-ac75-f015b4f3a43a2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4ee4feec-4590-fa7f-e063-6394a90a55502026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEHAWAII REPACK, INC.cf5d4de9-79c3-4935-be69-89e98d7b54cc2026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPdfe7288c-a477-4f32-a9ab-00cc981a1a572026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.5d536e88-62be-45bd-bd09-0efc53fe12b92026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEUnit Dose Solutions, Inc.53bef1ab-55c0-cc52-e063-6394a90a12b32026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
ndc (package): 87441-010-01
ndc (product): 87441-010
ndc11 (package): 87441001001
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACYfe81c68d-a579-4fe9-e053-6294a90a7bc02026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY00b20a8c-debd-e930-e063-6394a90a7ed02026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECoupler LLC5023b8a5-c9df-84a4-e063-6294a90a96062026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEQPharma, Inc.4dcbdf8f-37ce-0f90-e063-6394a90ae83c2026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.8bef97d4-1b92-4316-8733-7751d627230f2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.2f89c8f6-7f3c-8396-e063-6294a90a643e2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDESportpharm LLC24653b10-bdf0-47c5-a1f4-dc25f3b860322026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.e4e8bab3-c5e7-4d2b-9692-ee6c6799b1202026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.e343fd12-1ca2-418a-b690-f3e8f567596d2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEDirect_Rx15aad4af-5c05-be36-e063-6294a90a9bb32026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4c3a3b4f-7b2b-3fe9-e063-6394a90aae472026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackdc3cc6b6-c692-4986-8ff7-3a6cd8c85cb22026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.06da53af-5b46-4e32-a64c-9677e27ae2292026-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208170
application number: ANDA208170

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
53bef1ab-55c0-cc52-e063-6394a90a12b3Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
87441-010-018744100100130 TABLET, FILM COATED in 1 BLISTER PACK (87441-010-01)2026-06-080Current