PHENADOZ

Product NDC
50090-3897
11-digit product format
500903897
Labeler code
50090
Product ID
50090-3897_4c253dcf-dfe4-48f7-8853-5c784e7557a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
A-S Medication Solutions
Application
ANDA040428
Marketing category
ANDA
Marketing start
2015-03-16
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
13 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
50090-3897-02023-01-30C16284748780-1f386c64a-1506-0266-e053-dadaa90a7c1aPHENADOZ ® PROMETHAZINE HCl SUPPOSITORIES, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3897-0PHENADOZ1 in 1 PACKETSUPPOSITORY14
50090-3897-0PHENADOZ12 in 1 BOXSUPPOSITORY124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3897PHENADOZ (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20200121_5716b0d8-0efc-44aa-a17e-a51f24a0c8f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992443Phenadoz 12.5 MG Rectal SuppositoryPSN5716b0d8-0efc-44aa-a17e-a51f24a0c8f14
992441promethazine HCl 12.5 MG Rectal SuppositoryPSN5716b0d8-0efc-44aa-a17e-a51f24a0c8f14
992443promethazine hydrochloride 12.5 MG Rectal Suppository [Phenadoz]SBD5716b0d8-0efc-44aa-a17e-a51f24a0c8f14
992441promethazine hydrochloride 12.5 MG Rectal SuppositorySCD5716b0d8-0efc-44aa-a17e-a51f24a0c8f14
992443Phenadoz 12.5 MG Rectal SuppositorySY5716b0d8-0efc-44aa-a17e-a51f24a0c8f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3897-05009038970012 PACKET in 1 BOX (50090-3897-0) > 1 SUPPOSITORY in 1 PACKET12 packet2018-12-040000-00-00NoNoCurrent