FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
81033-016
11-digit product format
810330016
Labeler code
81033
Product ID
81033-016_303b389f-b276-52cb-e063-6294a90a6e2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
ANDA040891
Marketing category
ANDA
Marketing start
2024-12-31
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
81033-016-05PROMETHAZINE HYDROCHLORIDE5 mL in 1 CUP, UNIT-DOSESOLUTION55
81033-016-50PROMETHAZINE HYDROCHLORIDE50 in 1 CARTONSOLUTION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-016-05ML - Milliliter81033-01667c1adab-b297-4f5f-b0f8-f569a23ecd0612024-12-10
81033-016-50ML - Milliliter81033-016d3d3f10b-a55c-43be-9d65-db491217cd3c12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-016PROMETHAZINE HYDROCHLORIDE SOLUTION [KESIN PHARMA CORPORATION]5Current NDC, 2 package rows20250316_28793bd2-bd40-4571-e063-6394a90ae789.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN28793bd2-bd40-4571-e063-6394a90ae7895
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD28793bd2-bd40-4571-e063-6394a90ae7895
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSY28793bd2-bd40-4571-e063-6394a90ae7895

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-016-05810330016055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-016-508103300165050 CUP, UNIT-DOSE in 1 CARTON (81033-016-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-016-05) 2024-12-31NoNoCurrent