Cyclobenzaprine hydrochloride

Product NDC
68071-4415
11-digit product format
680714415
Labeler code
68071
Product ID
68071-4415_6b65c4ae-4ddc-0678-e053-2a91aa0a01ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA073541
Marketing category
ANDA
Marketing start
2017-06-01
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-4415DDiscontinued by firm2026-08-03
excluded packagepackage68071-441568071-4415-1DDiscontinued by firm2026-08-03
excluded packagepackage68071-441568071-4415-2DDiscontinued by firm2026-08-03
excluded packagepackage68071-441568071-4415-3DDiscontinued by firm2026-08-03
excluded packagepackage68071-441568071-4415-4DDiscontinued by firm2026-08-03
excluded packagepackage68071-441568071-4415-6DDiscontinued by firm2026-08-03
excluded packagepackage68071-441568071-4415-9DDiscontinued by firm2026-08-03

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 2 · 91 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 packagepackage68071-4415-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-4415-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-4415-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-4415-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-4415-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-4415-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-4415-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-4415-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-4415-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-4415-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-4415-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-4415-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-4415-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-4415-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-4415-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-4415-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-4415-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-4415-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-4415-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-4415-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-4415-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-4415-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-4415-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-4415-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-4415-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-4415-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-4415-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-4415-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-4415-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-4415-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-4415-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-4415-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-4415-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-4415-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-4415-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-4415-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-4415-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-4415-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-4415-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-4415-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-4415-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-4415-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-4415-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-4415-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-4415-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-4415-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-4415-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-4415-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-4415-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-4415-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-4415-60efc9e666f02…f202fb6c5f17…

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
A073541-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23
A073541-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A073541-001AB
A073541-002AB

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 UTC2026-02A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06782e0a99824c…

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 UTC2026-02A073541-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073541-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073541-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073541-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073541-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073541-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073541-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073541-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073541-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073541-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073541-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073541-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073541-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073541-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073541-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073541-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073541-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073541-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073541-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073541-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073541-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073541-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073541-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073541-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073541-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073541-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073541-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A073541-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073541-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073541-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073541-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A073541-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073541-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A073541-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073541-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A073541-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073541-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A073541-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073541-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A073541-002AB1782e0a99824c…

FDA-Initiated Inactive NDC Indexing#