FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
85766-108
11-digit product format
857660108
Labeler code
85766
Product ID
85766-108_5031f5dd-9200-472d-e063-6394a90ad8aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA040596
Marketing category
ANDA
Marketing start
2005-12-14
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Promethazine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE12.5 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
85766-108-00Promethazine Hydrochloride1000 in 1 BOTTLETABLET10002
85766-108-01Promethazine Hydrochloride100 in 1 BOTTLETABLET1002
85766-108-05Promethazine Hydrochloride500 in 1 BOTTLETABLET5002
85766-108-10Promethazine Hydrochloride10 in 1 BOTTLETABLET102
85766-108-20Promethazine Hydrochloride20 in 1 BOTTLETABLET202
85766-108-30Promethazine Hydrochloride30 in 1 BOTTLETABLET302
85766-108-60Promethazine Hydrochloride60 in 1 BOTTLETABLET602
85766-108-90Promethazine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992438promethazine HCl 12.5 MG Oral TabletPSN4156e780-7ecf-bcae-e063-6394a90a2ae22
992447promethazine HCl 25 MG Oral TabletPSN4156e780-7ecf-bcae-e063-6394a90a2ae22
992475promethazine HCl 50 MG Oral TabletPSN4156e780-7ecf-bcae-e063-6394a90a2ae22
992438promethazine hydrochloride 12.5 MG Oral TabletSCD4156e780-7ecf-bcae-e063-6394a90a2ae22
992447promethazine hydrochloride 25 MG Oral TabletSCD4156e780-7ecf-bcae-e063-6394a90a2ae22
992475promethazine hydrochloride 50 MG Oral TabletSCD4156e780-7ecf-bcae-e063-6394a90a2ae22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-108-00857660108001000 TABLET in 1 BOTTLE (85766-108-00) 1000 tablet2025-10-17NoNoHistorical
85766-108-0185766010801100 TABLET in 1 BOTTLE (85766-108-01) 100 tablet2025-10-17NoNoHistorical
85766-108-0585766010805500 TABLET in 1 BOTTLE (85766-108-05) 500 tablet2025-10-17NoNoHistorical
85766-108-108576601081010 TABLET in 1 BOTTLE (85766-108-10) 10 tablet2025-10-17NoNoHistorical
85766-108-208576601082020 TABLET in 1 BOTTLE (85766-108-20) 20 tablet2025-10-17NoNoHistorical
85766-108-308576601083030 TABLET in 1 BOTTLE (85766-108-30) 30 tablet2025-10-17NoNoHistorical
85766-108-608576601086060 TABLET in 1 BOTTLE (85766-108-60) 60 tablet2025-10-17NoNoHistorical
85766-108-908576601089090 TABLET in 1 BOTTLE (85766-108-90) 90 tablet2025-10-17NoNoHistorical