Promethazine Hydrochloride

Product NDC
67296-1120
11-digit product format
672961120
Labeler code
67296
Product ID
67296-1120_d60fe5a0-f3a5-7fa7-e053-2995a90a72d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA091179
Marketing category
ANDA
Marketing start
2011-03-03
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
67296-1120-12024-01-30C16284748780-11030e364-ff39-111a-e063-dadaa90a10e24ea41402-f085-45ac-e054-00144ff88e88
67296-1120-52024-01-30C16284748780-11030e364-ff39-111a-e063-dadaa90a10e24ea41402-f085-45ac-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1120-1Promethazine Hydrochloride5 in 1 BOTTLETABLET53
67296-1120-5Promethazine Hydrochloride15 in 1 BOTTLETABLET153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1120PROMETHAZINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]3Legacy NDC, 2 package rows20220121_4ea41402-f085-45ac-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN4ea41402-f085-45ac-e054-00144ff88e883
992447promethazine hydrochloride 25 MG Oral TabletSCD4ea41402-f085-45ac-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1120-1672961120015 TABLET in 1 BOTTLE (67296-1120-1) 5 tablet2011-03-030000-00-00NoNoCurrent
67296-1120-56729611200515 TABLET in 1 BOTTLE (67296-1120-5) 15 tablet2011-03-030000-00-00NoNoCurrent