FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
68071-4865
11-digit product format
680714865
Labeler code
68071
Product ID
68071-4865_1ae1b7ed-1e35-1077-e063-6394a90a791e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040596
Marketing category
ANDA
Marketing start
2005-12-14
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4865-62021-02-17C16284748780-1ba0f9c33-3b10-a910-e053-dadaa90a0b85Promethazine Hydrochloride Tablets USP
68071-4865-62021-01-29C16284748780-1ba0f9c33-3b10-a910-e053-dadaa90a0b85Promethazine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4865-4Promethazine Hydrochloride4 in 1 BOTTLETABLET46
68071-4865-6Promethazine Hydrochloride6 in 1 BOTTLETABLET66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4865PROMETHAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 2 package rows20240616_8749824b-6d66-430d-e053-2995a90a2db8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN8749824b-6d66-430d-e053-2995a90a2db86
992447promethazine hydrochloride 25 MG Oral TabletSCD8749824b-6d66-430d-e053-2995a90a2db86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4865-4680714865044 TABLET in 1 BOTTLE (68071-4865-4) 4 tablet2019-04-240000-00-00NoNoCurrent
68071-4865-6680714865066 TABLET in 1 BOTTLE (68071-4865-6) 6 tablet2019-04-240000-00-00NoNoCurrent