FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
10702-002
11-digit product format
107020002
Labeler code
10702
Product ID
10702-002_4ceccb65-dd65-461c-e063-6294a90afcda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA040712
Marketing category
ANDA
Marketing start
2007-05-04
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
12.5 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 HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992438, 992447, 992475

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
10702-002-012024-02-09C16284748780-11030e365-66e8-111a-e063-dadaa90a10e2PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-002-102024-02-09C16284748780-11030e365-66e8-111a-e063-dadaa90a10e2PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-002-012024-01-30C16284748780-11030e365-66e8-111a-e063-dadaa90a10e2PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-002-102024-01-30C16284748780-11030e365-66e8-111a-e063-dadaa90a10e2PROMETHAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-002-01PROMETHAZINE HYDROCHLORIDE100 in 1 BOTTLETABLET10013
10702-002-10PROMETHAZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-002PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]12Current NDC, Legacy NDC, 2 package rows20240502_7a137adf-39b7-4b14-80da-c3cac9ad562a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992438promethazine HCl 12.5 MG Oral TabletPSNb0ba50da-9f70-4531-a9de-3dd3f8aa1f5d19
992438promethazine hydrochloride 12.5 MG Oral TabletSCDb0ba50da-9f70-4531-a9de-3dd3f8aa1f5d19
992438promethazine HCl 12.5 MG Oral TabletPSN7a137adf-39b7-4b14-80da-c3cac9ad562a13
992447promethazine HCl 25 MG Oral TabletPSN7a137adf-39b7-4b14-80da-c3cac9ad562a13
992475promethazine HCl 50 MG Oral TabletPSN7a137adf-39b7-4b14-80da-c3cac9ad562a13
992438promethazine hydrochloride 12.5 MG Oral TabletSCD7a137adf-39b7-4b14-80da-c3cac9ad562a13
992447promethazine hydrochloride 25 MG Oral TabletSCD7a137adf-39b7-4b14-80da-c3cac9ad562a13
992475promethazine hydrochloride 50 MG Oral TabletSCD7a137adf-39b7-4b14-80da-c3cac9ad562a13
992438promethazine HCl 12.5 MG Oral TabletPSN857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992447promethazine HCl 25 MG Oral TabletPSN857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992438promethazine hydrochloride 12.5 MG Oral TabletSCD857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992447promethazine hydrochloride 25 MG Oral TabletSCD857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992438promethazine HCl 12.5 MG Oral TabletPSNf9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c477
992438promethazine hydrochloride 12.5 MG Oral TabletSCDf9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-002-0110702000201100 TABLET in 1 BOTTLE (10702-002-01) 100 tablet2007-05-040000-00-00NoNoCurrent
10702-002-10107020002101000 TABLET in 1 BOTTLE (10702-002-10) 1000 tablet2007-05-040000-00-00NoNoCurrent