Cyclobenzaprine Hydrochloride

Product NDC
52959-042
11-digit product format
529590042
Labeler code
52959
Product ID
52959-042_5da7b877-db35-d9af-e053-2a91aa0aa7a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H. J Harkins Company Inc
Application
ANDA077797
Marketing category
ANDA
Marketing start
2017-01-03
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-042IInactivated by FDA2026-08-11
excluded packagepackage52959-04252959-042-00IInactivated by FDA2026-08-11
excluded packagepackage52959-04252959-042-06IInactivated by FDA2026-08-11
excluded packagepackage52959-04252959-042-10IInactivated by FDA2026-08-11
excluded packagepackage52959-04252959-042-15IInactivated by FDA2026-08-11
excluded packagepackage52959-04252959-042-20IInactivated by FDA2026-08-11
excluded packagepackage52959-04252959-042-21IInactivated by FDA2026-08-11
excluded packagepackage52959-04252959-042-30IInactivated by FDA2026-08-11
excluded packagepackage52959-04252959-042-60IInactivated by FDA2026-08-11
excluded packagepackage52959-04252959-042-90IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 4 · 220 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-042-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-042-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-042-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-042-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-042-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-042-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-042-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-042-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-042-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-042-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-042-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-042-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-042-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-042-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-042-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-042-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-042-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-042-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-042-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-042-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-042-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-042-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-042-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-042-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-042-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-042-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-042-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-042-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-042-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-042-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-042-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-042-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-042-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-042-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-042-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-042-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-042-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-042-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-042-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-042-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-042-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-042-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-042-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-042-00cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-042-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-042-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-042-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-042-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-042-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-042-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-042-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-042-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-042-00cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-042-21cdf11ea48f46…ba0047e9e063…

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
A077797-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28
A077797-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077797-001AB
A077797-002AB

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 UTC2026-02A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077797-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2007-02-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A077797-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2007-02-28782e0a99824c…

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 UTC2026-02A077797-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077797-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077797-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077797-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077797-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077797-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077797-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077797-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077797-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077797-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077797-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077797-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077797-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077797-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077797-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077797-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077797-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077797-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077797-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077797-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077797-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077797-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077797-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077797-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077797-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077797-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077797-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077797-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077797-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077797-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077797-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077797-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077797-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077797-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077797-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077797-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077797-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077797-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077797-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077797-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-042-60Therabenzaprine-9060 in 1 BOTTLETABLET, FILM COATED6010 mg9
52959-042-60Therabenzaprine-6060 in 1 BOTTLETABLET6010 mg4
52959-042-00Cyclobenzaprine Hydrochloride100 in 1 CONTAINERTABLET, FILM COATED1001
52959-042-06Cyclobenzaprine Hydrochloride6 in 1 CONTAINERTABLET, FILM COATED61
52959-042-10Cyclobenzaprine Hydrochloride10 in 1 CONTAINERTABLET, FILM COATED101
52959-042-15Cyclobenzaprine Hydrochloride15 in 1 CONTAINERTABLET, FILM COATED151
52959-042-20Cyclobenzaprine Hydrochloride20 in 1 CONTAINERTABLET, FILM COATED201
52959-042-21Cyclobenzaprine Hydrochloride21 in 1 CONTAINERTABLET, FILM COATED211
52959-042-30Cyclobenzaprine Hydrochloride30 in 1 CONTAINERTABLET, FILM COATED301
52959-042-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
52959-042-90Cyclobenzaprine Hydrochloride90 in 1 CONTAINERTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-042-00EA - Each52959-042b8ff0445-e08a-4db5-8447-02251474dfcc12017-12-14
52959-042-10EA - Each52959-042bfb88d68-5f3e-4566-8d47-3713eea1357c12017-12-14
52959-042-15EA - Each52959-04258bdae87-3230-4418-8a70-1cc4298d664f12017-12-14
52959-042-20EA - Each52959-04263cd6ad6-041a-4459-9c52-b4675e59ffd012017-12-14
52959-042-21EA - Each52959-042a549ba4a-edb2-4338-b512-3eec42168a4f12017-12-14
52959-042-30EA - Each52959-0426fdd8a16-98e8-4e84-9072-81302825a3e012017-12-14
52959-042-60EA - Each52959-0429eb41ad3-5cd0-4de5-9d1c-0a04e5229a3612017-12-14
52959-042-90EA - Each52959-042d86df2b7-0887-46b8-b0e4-566a4075225412017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PTHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TITHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
GELATININACTIVE INGREDIENT2G86QN327LTHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTHERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TITHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
GELATININACTIVE INGREDIENT2G86QN327LTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTHERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-042THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]9Legacy NDC20110815_6f49de96-1090-46bc-b7bf-0dc70f7d9530.zip
52959-042THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]4Legacy NDC20110812_b016f51f-82c2-498d-83f1-51e01505a0ae.zip
52959-042CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [H. J HARKINS COMPANY INC]1Legacy NDC, 9 package rows20171114_5da7b877-db34-d9af-e053-2a91aa0aa7a0.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEGolden State Medical Supply, Inc.15c0c7aa-8c54-4040-a1bf-2a7b421ad33f2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.59b428fa-5013-4b2b-872f-16ba4a9d4f5d2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9161cb5e-63e5-41d7-9bde-66c7b7b7a2f32025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3aaa4808-7f2d-410c-9b6c-193549ec08452025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7829a96a-3668-4d88-90e9-0ecbedb2bd7e2025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3baeda95-d098-437a-b360-87a9c3f3fd9b2025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackaa29e260-fb77-415a-a505-3230d30c89452025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLCafcad582-ab59-4f70-e053-2a95a90a04e42024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack4c51f56b-33c3-4611-bba8-876d9dde7aff2024-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack90c7a982-6442-4241-a60b-b5dfab2abb712024-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackc86303a0-7c8b-415e-acac-1070b7d0d4452024-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.68db3c3b-8da1-4852-90b0-3172f842aa022023-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESolco Healthcare U.S., LLCf558863b-ea3f-4e4b-85e9-edb2573e71512022-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCbe5201bc-e1f1-41af-be46-4a8fbb223b862020-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LP571fbb2b-24e0-4de3-8cfa-c267fc397b6c2019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077797
application number: ANDA077797

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN6f49de96-1090-46bc-b7bf-0dc70f7d95309
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD6f49de96-1090-46bc-b7bf-0dc70f7d95309
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb016f51f-82c2-498d-83f1-51e01505a0ae4
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDb016f51f-82c2-498d-83f1-51e01505a0ae4
828348cyclobenzaprine HCl 10 MG Oral TabletPSN5da7b877-db34-d9af-e053-2a91aa0aa7a01
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD5da7b877-db34-d9af-e053-2a91aa0aa7a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-042-0052959004200100 in 1 CONTAINERHistorical
52959-042-06529590042066 in 1 CONTAINERHistorical
52959-042-105295900421010 in 1 CONTAINERHistorical
52959-042-155295900421515 in 1 CONTAINERHistorical
52959-042-205295900422020 in 1 CONTAINERHistorical
52959-042-215295900422121 in 1 CONTAINERHistorical
52959-042-305295900423030 in 1 CONTAINERHistorical
52959-042-605295900426060 in 1 BOTTLEHistorical
52959-042-905295900429090 in 1 CONTAINERHistorical