FDA.reportPublic FDA data

PHENADOZ

Product NDC
50090-3894
11-digit product format
500903894
Labeler code
50090
Product ID
50090-3894_97ebeb4c-4d6c-4f8d-9e65-21e1906dede3
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
2015-02-17
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
2022-12-31
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
50090-3894-02023-01-30C16284748780-1f386c64a-3f2f-0266-e053-dadaa90a7c1aPHENADOZ ® PROMETHAZINE HCl SUPPOSITORIES, USP Rx Only
50090-3894-12023-01-30C16284748780-1f386c64a-3f2f-0266-e053-dadaa90a7c1aPHENADOZ ® PROMETHAZINE HCl SUPPOSITORIES, USP Rx Only
50090-3894-22023-01-30C16284748780-1f386c64a-3f2f-0266-e053-dadaa90a7c1aPHENADOZ ® PROMETHAZINE HCl SUPPOSITORIES, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3894-0PHENADOZ1 in 1 PACKETSUPPOSITORY18
50090-3894-0PHENADOZ12 in 1 BOXSUPPOSITORY128
50090-3894-1PHENADOZ4 in 1 BOXSUPPOSITORY48
50090-3894-1PHENADOZ1 in 1 PACKETSUPPOSITORY18
50090-3894-2PHENADOZ12 in 1 BOXSUPPOSITORY128
50090-3894-2PHENADOZ1 in 1 PACKETSUPPOSITORY18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3894-1EA - Each50090-3894733ce776-5706-41b2-aca2-cc511436c25b12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3894PHENADOZ (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [A-S MEDICATION SOLUTIONS]8Legacy NDC, 6 package rows20210303_fd8cc8e0-edf1-4599-a7bc-2e924a8c859c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992456Phenadoz 25 MG Rectal SuppositoryPSNfd8cc8e0-edf1-4599-a7bc-2e924a8c859c8
992454promethazine HCl 25 MG Rectal SuppositoryPSNfd8cc8e0-edf1-4599-a7bc-2e924a8c859c8
992456promethazine hydrochloride 25 MG Rectal Suppository [Phenadoz]SBDfd8cc8e0-edf1-4599-a7bc-2e924a8c859c8
992454promethazine hydrochloride 25 MG Rectal SuppositorySCDfd8cc8e0-edf1-4599-a7bc-2e924a8c859c8
992456Phenadoz 25 MG Rectal SuppositorySYfd8cc8e0-edf1-4599-a7bc-2e924a8c859c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3894-05009038940012 PACKET in 1 BOX (50090-3894-0) > 1 SUPPOSITORY in 1 PACKET12 packet2018-12-040000-00-00NoNoCurrent
50090-3894-1500903894014 PACKET in 1 BOX (50090-3894-1) > 1 SUPPOSITORY in 1 PACKET4 packet2018-12-130000-00-00NoNoCurrent
50090-3894-25009038940212 PACKET in 1 BOX (50090-3894-2) > 1 SUPPOSITORY in 1 PACKET12 packet2018-12-040000-00-00NoNoCurrent