FDA.reportPublic FDA data

Promethegan

Product NDC
21695-959
11-digit product format
216950959
Labeler code
21695
Product ID
21695-959_c809171c-d424-4a17-a98d-f280a892b410
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Rebel Distributors Corp
Application
ANDA040428
Marketing category
ANDA
Marketing start
2002-02-05
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-959-122019-09-24C16284748780-1934fe258-4974-48b1-e053-8cdaa90a720aPROMETHAZINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-959-12Promethegan12 in 1 BOXSUPPOSITORY121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-959-12EA - Each21695-9590bc5c929-bcda-42ca-9684-cd2e5be59e7112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-959PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110914_c809171c-d424-4a17-a98d-f280a892b410.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992454promethazine HCl 25 MG Rectal SuppositoryPSNc809171c-d424-4a17-a98d-f280a892b4101
992459PROMETHEGAN 25 MG Rectal SuppositoryPSNc809171c-d424-4a17-a98d-f280a892b4101
992459promethazine hydrochloride 25 MG Rectal Suppository [Promethegan]SBDc809171c-d424-4a17-a98d-f280a892b4101
992454promethazine hydrochloride 25 MG Rectal SuppositorySCDc809171c-d424-4a17-a98d-f280a892b4101
992459Promethegan 25 MG Rectal SuppositorySYc809171c-d424-4a17-a98d-f280a892b4101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-959-122169509591212 in 1 BOXHistorical