FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
33261-865
11-digit product format
332610865
Labeler code
33261
Product ID
33261-865_e06b299b-b1b6-40db-94b3-30d476196771
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040712
Marketing category
ANDA
Marketing start
2012-07-17
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
13 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-865-302020-01-31C16284748780-19d75b9d0-6dc0-f424-e053-dadaa90a57ceUnknown Title

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-865-30Promethazine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-865-30EA - Each33261-86551054ffc-3ec1-4c46-9091-8c757273710912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
METHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JPROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-865PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]9Legacy NDC, 1 package rows20160813_857dd0a8-3e23-423c-9b5e-9a8779b4c7d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992438promethazine HCl 12.5 MG Oral TabletPSN857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992447promethazine HCl 25 MG Oral TabletPSN857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992438promethazine hydrochloride 12.5 MG Oral TabletSCD857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992447promethazine hydrochloride 25 MG Oral TabletSCD857dd0a8-3e23-423c-9b5e-9a8779b4c7d09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-865-303326108653030 in 1 BOTTLE, PLASTICHistorical