FDA.reportPublic FDA data

Promethazine hydrochloride

Product NDC
51655-114
11-digit product format
516550114
Labeler code
51655
Product ID
51655-114_6403bb54-d54c-46a4-876c-b5dcbe7660d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA040596
Marketing category
ANDA
Marketing start
2014-05-20
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
51655-114-522026-01-06C16284748780-19d75b9d0-1c75-f424-e053-dadaa90a57cea5125d27-5258-41ec-b4aa-ca999d97a432
51655-114-532026-01-06C16284748780-19d75b9d0-1c75-f424-e053-dadaa90a57cea5125d27-5258-41ec-b4aa-ca999d97a432
51655-114-522020-01-31C16284748780-19d75b9d0-1c75-f424-e053-dadaa90a57cea5125d27-5258-41ec-b4aa-ca999d97a432
51655-114-532020-01-31C16284748780-19d75b9d0-1c75-f424-e053-dadaa90a57cea5125d27-5258-41ec-b4aa-ca999d97a432

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-114PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2Legacy NDC20150401_a5125d27-5258-41ec-b4aa-ca999d97a432.zip