Fexmid

Product NDC
53149-4850
Requested package NDC
53149-4850-6
11-digit product format
531494850
Labeler code
53149
Product ID
53149-4850_84b2a2f5-7806-488a-ae52-5616932254fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
All Pharma, LLC
Application
ANDA071611
Marketing category
ANDA
Marketing start
2018-04-30
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53149-485053149-4850-6IInactivated 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 1 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
A071611-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03
A071611-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03
A071611-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071611-001AB
A071611-002AB
A071611-003AB

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 UTC2026-02A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-038072bd15b7f6…

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 UTC2026-02A071611-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071611-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071611-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071611-001AB18072bd15b7f6…

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
53149-4850-1Fexmid120 in 1 BOTTLETABLET, FILM COATED1204
53149-4850-3Fexmid30 in 1 BOTTLETABLET, FILM COATED304
53149-4850-6Fexmid60 in 1 BOTTLETABLET, FILM COATED604
53149-4850-9Fexmid90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53149-4850-1EA - Each53149-4850a3a21a25-d403-4ad3-984a-4feb43f03f1212019-02-13
53149-4850-3EA - Each53149-485087d82897-ddbf-4883-991e-3656b78ce00a12019-02-13
53149-4850-6EA - Each53149-485084edcdb1-639c-40b4-8450-ff11a0d6e64b12019-02-13
53149-4850-9EA - Each53149-4850c6bd755c-da91-47d7-963a-bc210803996f12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-4850FEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [ALL PHARMA, LLC]4Legacy NDC, 4 package rows20200117_d6057052-1b8f-4e6d-a386-026751d81da5.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.1d9e34cc-eee9-4147-abf8-c810a80e39d22026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071611
application number: ANDA071611
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1ac77323-7526-a129-e063-6394a90a641b2024-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071611
application number: ANDA071611
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.f8dec4e2-3151-4a79-b194-a11a57ada0b62022-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071611
application number: ANDA071611

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNd6057052-1b8f-4e6d-a386-026751d81da54
828301Fexmid 7.5 MG Oral TabletPSNd6057052-1b8f-4e6d-a386-026751d81da54
828301cyclobenzaprine hydrochloride 7.5 MG Oral Tablet [Fexmid]SBDd6057052-1b8f-4e6d-a386-026751d81da54
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDd6057052-1b8f-4e6d-a386-026751d81da54
828301Fexmid 7.5 MG Oral TabletSYd6057052-1b8f-4e6d-a386-026751d81da54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53149-4850-65314948500660 TABLET, FILM COATED in 1 BOTTLE (53149-4850-6) 2018-08-130000-00-00NoNoCurrent