FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
70934-253
11-digit product format
709340253
Labeler code
70934
Product ID
70934-253_8a1e9de0-f533-4266-e053-2a95a90a8480
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA071611
Marketing category
ANDA
Marketing start
2019-01-25
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-253-202023-01-18C16284748780-1ba0f9c33-1cfa-a910-e053-dadaa90a0b858a1eae05-bcb8-180c-e053-2995a90a349e
70934-253-302023-01-18C16284748780-1ba0f9c33-1cfa-a910-e053-dadaa90a0b858a1eae05-bcb8-180c-e053-2995a90a349e
70934-253-202021-01-29C16284748780-1ba0f9c33-1cfa-a910-e053-dadaa90a0b858a1eae05-bcb8-180c-e053-2995a90a349e
70934-253-302021-01-29C16284748780-1ba0f9c33-1cfa-a910-e053-dadaa90a0b858a1eae05-bcb8-180c-e053-2995a90a349e