FDA.reportPublic FDA data

Promethazine hydrochloride

Product NDC
51655-588
11-digit product format
516550588
Labeler code
51655
Product ID
51655-588_0e68f892-a948-44db-9fca-cb3f798fdde0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA040596
Marketing category
ANDA
Marketing start
2014-05-19
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/301
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-588-532026-01-08C16284748780-19d75b9d0-a8dc-f424-e053-dadaa90a57ce0a9b26e5-c31c-41a9-addd-9ce9a7878dc0
51655-588-532020-01-31C16284748780-19d75b9d0-a8dc-f424-e053-dadaa90a57ce0a9b26e5-c31c-41a9-addd-9ce9a7878dc0

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-588PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140527_0a9b26e5-c31c-41a9-addd-9ce9a7878dc0.zip