FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
50090-4453
11-digit product format
500904453
Labeler code
50090
Product ID
50090-4453_19340230-9333-4d07-aa1b-708485519db2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040712
Marketing category
ANDA
Marketing start
2006-07-31
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4453-02023-02-07C16284748780-1f386c64a-38db-0266-e053-dadaa90a7c1aPROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-12023-02-07C16284748780-1f386c64a-38db-0266-e053-dadaa90a7c1aPROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-52023-02-07C16284748780-1f386c64a-38db-0266-e053-dadaa90a7c1aPROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-62023-02-07C16284748780-1f386c64a-38db-0266-e053-dadaa90a7c1aPROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-92023-02-07C16284748780-1f386c64a-38db-0266-e053-dadaa90a7c1aPROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-02023-01-30C16284748780-1f386c64a-38db-0266-e053-dadaa90a7c1aPROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-12023-01-30C16284748780-1f386c64a-38db-0266-e053-dadaa90a7c1aPROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-52023-01-30C16284748780-1f386c64a-38db-0266-e053-dadaa90a7c1aPROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-62023-01-30C16284748780-1f386c64a-38db-0266-e053-dadaa90a7c1aPROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-92023-01-30C16284748780-1f386c64a-38db-0266-e053-dadaa90a7c1aPROMETHAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4453-0PROMETHAZINE HYDROCHLORIDE12 in 1 BOTTLETABLET1210
50090-4453-1PROMETHAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET1010
50090-4453-5PROMETHAZINE HYDROCHLORIDE60 in 1 BOTTLETABLET6010
50090-4453-6PROMETHAZINE HYDROCHLORIDE20 in 1 BOTTLETABLET2010
50090-4453-9PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4453PROMETHAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 5 package rows20230510_2c9a4767-23c4-4a1c-bb4c-2bad1351c270.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN2c9a4767-23c4-4a1c-bb4c-2bad1351c27010
992447promethazine hydrochloride 25 MG Oral TabletSCD2c9a4767-23c4-4a1c-bb4c-2bad1351c27010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4453-05009044530012 TABLET in 1 BOTTLE (50090-4453-0) 12 tablet2019-08-050000-00-00NoNoCurrent
50090-4453-15009044530110 TABLET in 1 BOTTLE (50090-4453-1) 10 tablet2019-08-050000-00-00NoNoCurrent
50090-4453-55009044530560 TABLET in 1 BOTTLE (50090-4453-5) 60 tablet2019-08-050000-00-00NoNoCurrent
50090-4453-65009044530620 TABLET in 1 BOTTLE (50090-4453-6) 20 tablet2019-08-050000-00-00NoNoCurrent
50090-4453-95009044530930 TABLET in 1 BOTTLE (50090-4453-9) 30 tablet2019-08-050000-00-00NoNoCurrent