PROMETHAZINE HYDROCHLORIDE

Product NDC
72162-2377
11-digit product format
721622377
Labeler code
72162
Product ID
72162-2377_30e03661-9498-4ac2-a59c-a0dd99d387ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040891
Marketing category
ANDA
Marketing start
2024-02-20
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
6.25 mg/5mL
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 HYDROCHLORIDE6.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992432

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
72162-2377-2PROMETHAZINE HYDROCHLORIDE473 mL in 1 BOTTLESOLUTION473100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2377-2ML - Milliliter72162-2377778a48a3-6c08-42b4-a978-9d9f691a360612024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2377PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE) SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240731_a4b3da5b-1129-43c2-bf22-3a29c3fae116.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNa4b3da5b-1129-43c2-bf22-3a29c3fae116100
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDa4b3da5b-1129-43c2-bf22-3a29c3fae116100
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYa4b3da5b-1129-43c2-bf22-3a29c3fae116100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2377-272162237702473 mL in 1 BOTTLE (72162-2377-2) 473 ml2024-07-30NoNoHistorical