FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
68071-4424
11-digit product format
680714424
Labeler code
68071
Product ID
68071-4424_2b36ea69-71a4-dc30-e063-6394a90a13f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040712
Marketing category
ANDA
Marketing start
2006-07-31
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
68071-4424-12025-01-08C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42025-01-08C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62025-01-08C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-12023-01-30C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42023-01-30C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62023-01-30C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-12021-02-16C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42021-02-16C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62021-02-16C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-12021-01-29C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-42021-01-29C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP
68071-4424-62021-01-29C16284748780-1ba0f9c33-419d-a910-e053-dadaa90a0b85PROMETHAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4424-1PROMETHAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET103
68071-4424-4PROMETHAZINE HYDROCHLORIDE4 in 1 BOTTLETABLET43
68071-4424-6PROMETHAZINE HYDROCHLORIDE6 in 1 BOTTLETABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4424PROMETHAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 3 package rows20250110_6bcaa89f-5f14-dc45-e053-2a91aa0aac54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN6bcaa89f-5f14-dc45-e053-2a91aa0aac543
992447promethazine hydrochloride 25 MG Oral TabletSCD6bcaa89f-5f14-dc45-e053-2a91aa0aac543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4424-16807144240110 TABLET in 1 BOTTLE (68071-4424-1) 10 tablet2018-05-090000-00-00NoNoCurrent
68071-4424-4680714424044 TABLET in 1 BOTTLE (68071-4424-4) 4 tablet2018-05-090000-00-00NoNoCurrent
68071-4424-6680714424066 TABLET in 1 BOTTLE (68071-4424-6) 6 tablet2018-05-090000-00-00NoNoCurrent