FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
51655-112
11-digit product format
516550112
Labeler code
51655
Product ID
51655-112_cb8e448c-9616-462d-a412-94af74c2ad17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA040596
Marketing category
ANDA
Marketing start
2014-03-03
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
13 mg/1
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
51655-112-102026-01-04C16284748780-19d75b9d0-4741-f424-e053-dadaa90a57ce1ea20a7e-ebf1-4ba3-a7dd-61e0483e3b23
51655-112-102020-01-31C16284748780-19d75b9d0-4741-f424-e053-dadaa90a57ce1ea20a7e-ebf1-4ba3-a7dd-61e0483e3b23

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
51655-112PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140611_1ea20a7e-ebf1-4ba3-a7dd-61e0483e3b23.zip