FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
63187-829
11-digit product format
631870829
Labeler code
63187
Product ID
63187-829_a31e8f85-d588-4653-abf6-efe03da4149c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA083426
Marketing category
ANDA
Marketing start
1973-09-19
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-829-10Promethazine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET104
63187-829-12Promethazine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET124
63187-829-15Promethazine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET154
63187-829-20Promethazine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET204
63187-829-30Promethazine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET304
63187-829-60Promethazine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET604
63187-829-90Promethazine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-829-10EA - Each63187-8292157b028-d40b-4090-8cb5-46276ecbad9c12017-06-15
63187-829-12EA - Each63187-8297648558e-fd01-41c5-a95d-44951271b4c312018-05-09
63187-829-15EA - Each63187-829107fb738-8b4f-47ad-89bb-83f203b7e02412017-06-15
63187-829-20EA - Each63187-829a9e80682-375e-4df9-82be-0c9bb326df0812018-01-12
63187-829-30EA - Each63187-8298da7bd8d-f5f2-4b87-a7f8-152560726dd912017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-829PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 7 package rows20191113_08bf9fbf-cc21-41a0-9e81-ec498aa64170.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN08bf9fbf-cc21-41a0-9e81-ec498aa641704
992447promethazine hydrochloride 25 MG Oral TabletSCD08bf9fbf-cc21-41a0-9e81-ec498aa641704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-829-106318708291010 TABLET in 1 BOTTLE, PLASTIC (63187-829-10) 10 tablet2017-04-030000-00-00NoNoCurrent
63187-829-126318708291212 TABLET in 1 BOTTLE, PLASTIC (63187-829-12) 12 tablet2017-04-030000-00-00NoNoCurrent
63187-829-156318708291515 TABLET in 1 BOTTLE, PLASTIC (63187-829-15) 15 tablet2017-04-030000-00-00NoNoCurrent
63187-829-206318708292020 TABLET in 1 BOTTLE, PLASTIC (63187-829-20) 20 tablet2017-11-010000-00-00NoNoCurrent
63187-829-306318708293030 TABLET in 1 BOTTLE, PLASTIC (63187-829-30) 30 tablet2017-04-030000-00-00NoNoCurrent
63187-829-606318708296060 TABLET in 1 BOTTLE, PLASTIC (63187-829-60) 60 tablet2017-04-030000-00-00NoNoCurrent
63187-829-906318708299090 TABLET in 1 BOTTLE, PLASTIC (63187-829-90) 90 tablet2017-04-030000-00-00NoNoCurrent