FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
43063-405
11-digit product format
430630405
Labeler code
43063
Product ID
43063-405_4d621bb1-897f-caa7-e063-6294a90aaed8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091179
Marketing category
ANDA
Marketing start
2011-03-03
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
43063-405-04Promethazine Hydrochloride4 in 1 BOTTLE, PLASTICTABLET417
43063-405-05Promethazine Hydrochloride5 in 1 BOTTLE, PLASTICTABLET517
43063-405-06Promethazine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET617
43063-405-10Promethazine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET1017
43063-405-12Promethazine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET1217
43063-405-15Promethazine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET1517
43063-405-20Promethazine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET2017
43063-405-25Promethazine Hydrochloride25 in 1 BOTTLE, PLASTICTABLET2517
43063-405-30Promethazine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3017
43063-405-60Promethazine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6017
43063-405-79Promethazine Hydrochloride1 in 1 BOTTLE, PLASTICTABLET117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-405PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 11 package rows20250109_81fd29a9-c090-49ba-8b48-bd3656ca0c92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN81fd29a9-c090-49ba-8b48-bd3656ca0c9217
992447promethazine hydrochloride 25 MG Oral TabletSCD81fd29a9-c090-49ba-8b48-bd3656ca0c9217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-405-01430630405011 TABLET in 1 BOTTLE, PLASTIC (43063-405-01) 1 tablet2012-02-210000-00-00NoNoCurrent
43063-405-02430630405022 TABLET in 1 BOTTLE, PLASTIC (43063-405-02) 2 tablet2012-02-210000-00-00NoNoCurrent
43063-405-04430630405044 TABLET in 1 BOTTLE, PLASTIC (43063-405-04) 4 tablet2012-02-210000-00-00NoNoCurrent
43063-405-05430630405055 TABLET in 1 BOTTLE, PLASTIC (43063-405-05) 5 tablet2012-02-210000-00-00NoNoCurrent
43063-405-06430630405066 TABLET in 1 BOTTLE, PLASTIC (43063-405-06) 6 tablet2012-02-210000-00-00NoNoCurrent
43063-405-104306304051010 TABLET in 1 BOTTLE, PLASTIC (43063-405-10) 10 tablet2012-02-210000-00-00NoNoCurrent
43063-405-124306304051212 TABLET in 1 BOTTLE, PLASTIC (43063-405-12) 12 tablet2012-02-210000-00-00NoNoCurrent
43063-405-154306304051515 TABLET in 1 BOTTLE, PLASTIC (43063-405-15) 15 tablet2012-02-210000-00-00NoNoCurrent
43063-405-204306304052020 TABLET in 1 BOTTLE, PLASTIC (43063-405-20) 20 tablet2012-02-210000-00-00NoNoCurrent
43063-405-254306304052525 TABLET in 1 BOTTLE, PLASTIC (43063-405-25) 25 tablet2012-02-210000-00-00NoNoCurrent
43063-405-304306304053030 TABLET in 1 BOTTLE, PLASTIC (43063-405-30) 30 tablet2012-02-210000-00-00NoNoCurrent
43063-405-604306304056060 TABLET in 1 BOTTLE, PLASTIC (43063-405-60) 60 tablet2012-02-210000-00-00NoNoCurrent
43063-405-79430630405791 TABLET in 1 BOTTLE, PLASTIC (43063-405-79) 1 tablet2012-02-210000-00-00NoNoCurrent