FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
45802-759
11-digit product format
458020759
Labeler code
45802
Product ID
45802-759_14ed3375-f9ec-40bf-8529-cafc44c46f28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA040500
Marketing category
ANDA
Marketing start
2006-05-17
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Promethazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992441, 992454

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-759-00Promethazine Hydrochloride1 in 1 BLISTER PACKSUPPOSITORY116
45802-759-30Promethazine Hydrochloride12 in 1 CARTONSUPPOSITORY1216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-759-00EA - Each45802-759746555d8-d089-4d29-a28c-93926f76a56112015-03-03
45802-759-30EA - Each45802-75956ac9144-d794-49de-ad4a-1141c6e43e6112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]3
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]3
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]3
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]3
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]3
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-759PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PADAGIS ISRAEL PHARMACEUTICALS LTD]16Current NDC, Legacy NDC, 2 package rows20250522_047b9a7c-586b-4635-a63e-2c7ce9ec34e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992441promethazine HCl 12.5 MG Rectal SuppositoryPSN46b869e2-9305-43ae-bb15-919a6d09b6ff22
992454promethazine HCl 25 MG Rectal SuppositoryPSN46b869e2-9305-43ae-bb15-919a6d09b6ff22
992441promethazine hydrochloride 12.5 MG Rectal SuppositorySCD46b869e2-9305-43ae-bb15-919a6d09b6ff22
992454promethazine hydrochloride 25 MG Rectal SuppositorySCD46b869e2-9305-43ae-bb15-919a6d09b6ff22
992454promethazine HCl 25 MG Rectal SuppositoryPSN7d766cf7-a21c-4eaf-bbdc-00f2939ef19a18
992454promethazine hydrochloride 25 MG Rectal SuppositorySCD7d766cf7-a21c-4eaf-bbdc-00f2939ef19a18
992441promethazine HCl 12.5 MG Rectal SuppositoryPSN047b9a7c-586b-4635-a63e-2c7ce9ec34e716
992454promethazine HCl 25 MG Rectal SuppositoryPSN047b9a7c-586b-4635-a63e-2c7ce9ec34e716
992441promethazine hydrochloride 12.5 MG Rectal SuppositorySCD047b9a7c-586b-4635-a63e-2c7ce9ec34e716
992454promethazine hydrochloride 25 MG Rectal SuppositorySCD047b9a7c-586b-4635-a63e-2c7ce9ec34e716
992441promethazine HCl 12.5 MG Rectal SuppositoryPSN1b1cee64-c0b5-4da6-92d0-1769350a51811
992454promethazine HCl 25 MG Rectal SuppositoryPSN1b1cee64-c0b5-4da6-92d0-1769350a51811
992454promethazine HCl 25 MG Rectal SuppositoryPSN3087a1cb-fda5-4115-86b6-1cce480a2f8e1
992441promethazine hydrochloride 12.5 MG Rectal SuppositorySCD1b1cee64-c0b5-4da6-92d0-1769350a51811
992454promethazine hydrochloride 25 MG Rectal SuppositorySCD1b1cee64-c0b5-4da6-92d0-1769350a51811
992454promethazine hydrochloride 25 MG Rectal SuppositorySCD3087a1cb-fda5-4115-86b6-1cce480a2f8e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-759-00458020759001 in 1 BLISTER PACKHistorical
45802-759-304580207593012 BLISTER PACK in 1 CARTON (45802-759-30) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-759-00) 12 blister pack2006-05-170000-00-00NoNoCurrent