FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
65162-522
11-digit product format
651620522
Labeler code
65162
Product ID
65162-522_ce7bb9fa-e802-467c-b3e3-46f92abcdce8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA091179
Marketing category
ANDA
Marketing start
2011-03-03
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992438, 992447, 992475

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
65162-522-10Promethazine Hydrochloride100 in 1 BOTTLETABLET10019
65162-522-50Promethazine Hydrochloride500 in 1 BOTTLETABLET50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-522-10EA - Each65162-522fcfe7010-4d65-4d9d-870c-6cfcc066427112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]3
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-522PROMETHAZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC]19Current NDC, Legacy NDC, 2 package rows20241031_05907a49-537f-4bf2-8a5f-5e905f19fece.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992475promethazine HCl 50 MG Oral TabletPSN12400c65-f93b-47a5-8167-1fb14337130b23
992475promethazine hydrochloride 50 MG Oral TabletSCD12400c65-f93b-47a5-8167-1fb14337130b23
992438promethazine HCl 12.5 MG Oral TabletPSN05907a49-537f-4bf2-8a5f-5e905f19fece19
992447promethazine HCl 25 MG Oral TabletPSN05907a49-537f-4bf2-8a5f-5e905f19fece19
992475promethazine HCl 50 MG Oral TabletPSN05907a49-537f-4bf2-8a5f-5e905f19fece19
992438promethazine hydrochloride 12.5 MG Oral TabletSCD05907a49-537f-4bf2-8a5f-5e905f19fece19
992447promethazine hydrochloride 25 MG Oral TabletSCD05907a49-537f-4bf2-8a5f-5e905f19fece19
992475promethazine hydrochloride 50 MG Oral TabletSCD05907a49-537f-4bf2-8a5f-5e905f19fece19
992475promethazine HCl 50 MG Oral TabletPSN5cc95465-0134-d346-e053-2991aa0a23bb3
992475promethazine hydrochloride 50 MG Oral TabletSCD5cc95465-0134-d346-e053-2991aa0a23bb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-522-1065162052210100 TABLET in 1 BOTTLE (65162-522-10) 100 tablet2011-03-030000-00-00NoNoCurrent
65162-522-5065162052250500 TABLET in 1 BOTTLE (65162-522-50) 500 tablet2011-03-030000-00-00NoNoCurrent