FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
72189-176
11-digit product format
721890176
Labeler code
72189
Product ID
72189-176_4c499547-8472-59d0-e063-6394a90aec42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040596
Marketing category
ANDA
Marketing start
2021-02-09
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
72189-176-10PROMETHAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET107
72189-176-12PROMETHAZINE HYDROCHLORIDE12 in 1 BOTTLETABLET127
72189-176-20PROMETHAZINE HYDROCHLORIDE20 in 1 BOTTLETABLET207
72189-176-30PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET307
72189-176-90PROMETHAZINE HYDROCHLORIDE90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-176PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]6Current NDC, Legacy NDC, 5 package rows20250119_bae9c9c1-107f-0fcb-e053-2a95a90a75b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSNbae9c9c1-107f-0fcb-e053-2a95a90a75b27
992447promethazine hydrochloride 25 MG Oral TabletSCDbae9c9c1-107f-0fcb-e053-2a95a90a75b27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-176-107218901761010 TABLET in 1 BOTTLE (72189-176-10) 10 tablet2021-02-090000-00-00NoNoCurrent
72189-176-127218901761212 TABLET in 1 BOTTLE (72189-176-12) 12 tablet2021-02-090000-00-00NoNoCurrent
72189-176-207218901762020 TABLET in 1 BOTTLE (72189-176-20) 20 tablet2021-02-09NoNoCurrent
72189-176-307218901763030 TABLET in 1 BOTTLE (72189-176-30) 30 tablet2021-02-090000-00-00NoNoCurrent
72189-176-907218901769090 TABLET in 1 BOTTLE (72189-176-90) 90 tablet2021-02-09NoNoCurrent