FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
51655-462
11-digit product format
516550462
Labeler code
51655
Product ID
51655-462_490f04de-9945-ac09-e063-6394a90a7694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA040712
Marketing category
ANDA
Marketing start
2022-02-23
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992447

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
51655-462-20PROMETHAZINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICTABLET203
51655-462-27PROMETHAZINE HYDROCHLORIDE12 in 1 BOTTLE, PLASTICTABLET123
51655-462-52PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-462PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1Current NDC, 3 package rows20230328_d9cb1a44-d646-d9e9-e053-2995a90a24ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSNd9cb1a44-d646-d9e9-e053-2995a90a24ff3
992447promethazine hydrochloride 25 MG Oral TabletSCDd9cb1a44-d646-d9e9-e053-2995a90a24ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-462-205165504622020 TABLET in 1 BOTTLE, PLASTIC (51655-462-20) 20 tablet2025-06-30NoNoCurrent
51655-462-275165504622712 TABLET in 1 BOTTLE, PLASTIC (51655-462-27) 12 tablet2022-02-23NoNoCurrent
51655-462-525165504625230 TABLET in 1 BOTTLE, PLASTIC (51655-462-52) 30 tablet2022-02-23NoNoCurrent