Promethazine Hydrochloride

Product NDC
50090-2747
11-digit product format
500902747
Labeler code
50090
Product ID
50090-2747_341bc00d-005a-4914-ba57-483d54081cdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
A-S Medication Solutions
Application
ANDA040500
Marketing category
ANDA
Marketing start
2006-05-17
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
Rxcui992441, 992454

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2747-1Promethazine Hydrochloride4 in 1 CARTONSUPPOSITORY422
50090-2747-1Promethazine Hydrochloride1 in 1 BLISTER PACKSUPPOSITORY122
50090-2747-2Promethazine Hydrochloride1 in 1 BLISTER PACKSUPPOSITORY122
50090-2747-2Promethazine Hydrochloride6 in 1 CARTONSUPPOSITORY622

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2747-1EA - Each50090-2747e3fd7d8c-940a-4dd3-afa1-f20eefc262d512019-04-11
50090-2747-2EA - Each50090-27473f7c2b37-1b24-4e60-96ed-1d4655ec099a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2747PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 4 package rows20231211_46b869e2-9305-43ae-bb15-919a6d09b6ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992441promethazine HCl 12.5 MG Rectal SuppositoryPSN46b869e2-9305-43ae-bb15-919a6d09b6ff22
992454promethazine HCl 25 MG Rectal SuppositoryPSN46b869e2-9305-43ae-bb15-919a6d09b6ff22
992441promethazine hydrochloride 12.5 MG Rectal SuppositorySCD46b869e2-9305-43ae-bb15-919a6d09b6ff22
992454promethazine hydrochloride 25 MG Rectal SuppositorySCD46b869e2-9305-43ae-bb15-919a6d09b6ff22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2747-1500902747014 BLISTER PACK in 1 CARTON (50090-2747-1) / 1 SUPPOSITORY in 1 BLISTER PACK4 blister pack2017-01-050000-00-00NoNoCurrent
50090-2747-2500902747026 BLISTER PACK in 1 CARTON (50090-2747-2) / 1 SUPPOSITORY in 1 BLISTER PACK6 blister pack2017-01-110000-00-00NoNoCurrent