FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
70518-1306
11-digit product format
705181306
Labeler code
70518
Product ID
70518-1306_50270206-60a2-f62b-e063-6294a90a665f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040596
Marketing category
ANDA
Marketing start
2018-07-16
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
70518-1306-0Promethazine Hydrochloride30 in 1 BLISTER PACKTABLET3021
70518-1306-1Promethazine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET621
70518-1306-2Promethazine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET1521
70518-1306-3Promethazine Hydrochloride30 in 1 BLISTER PACKTABLET3021
70518-1306-4Promethazine Hydrochloride30 in 1 BLISTER PACKTABLET3021
70518-1306-5Promethazine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET1521
70518-1306-6Promethazine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET1021
70518-1306-7Promethazine Hydrochloride50 in 1 BOXTABLET5021
70518-1306-8Promethazine Hydrochloride1 in 1 POUCHTABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1306PROMETHAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]18Current NDC, Legacy NDC, 9 package rows20250510_9e4e57fa-4ce3-4b7b-be5a-381801ed0386.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN9e4e57fa-4ce3-4b7b-be5a-381801ed038621
992447promethazine hydrochloride 25 MG Oral TabletSCD9e4e57fa-4ce3-4b7b-be5a-381801ed038621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1306-07051813060030 in 1 BLISTER PACKHistorical
70518-1306-1705181306016 TABLET in 1 BOTTLE, PLASTIC (70518-1306-1) 6 tablet2020-09-090000-00-00NoNoCurrent
70518-1306-27051813060215 TABLET in 1 BOTTLE, PLASTIC (70518-1306-2) 15 tablet2020-12-140000-00-00NoNoCurrent
70518-1306-37051813060330 TABLET in 1 BLISTER PACK (70518-1306-3) 30 tablet2021-09-210000-00-00NoNoCurrent
70518-1306-47051813060430 TABLET in 1 BLISTER PACK (70518-1306-4) 30 tablet2023-01-17NoNoCurrent
70518-1306-57051813060515 in 1 BOTTLE, PLASTICHistorical
70518-1306-67051813060610 in 1 BOTTLE, PLASTICHistorical
70518-1306-77051813060750 POUCH in 1 BOX (70518-1306-7) / 1 TABLET in 1 POUCH (70518-1306-8) 50 pouch2026-04-22NoNoCurrent
70518-1306-8705181306081 in 1 POUCHHistorical