FDA.reportPublic FDA data

Cyclobenzaprine HCl

Product NDC
69584-148
11-digit product format
695840148
Labeler code
69584
Product ID
69584-148_d87716a8-936d-4319-b54f-f36e1e103037
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Oxford Pharmaceuticals, LLC
Application
ANDA077209
Marketing category
ANDA
Marketing start
2018-01-25
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69584-148DDiscontinued by firm2026-07-31
excluded packagepackage69584-14869584-148-10DDiscontinued by firm2026-07-31
excluded packagepackage69584-14869584-148-90DDiscontinued by firm2026-07-31

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
A077209-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2005-10-04
A077209-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077209-001AB
A077209-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077209-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2005-10-04a50c72e98297…
2026-08-01 22:54:322026-06A077209-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077209-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077209-002AB1a50c72e98297…