FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
0641-1496
11-digit product format
006411496
Labeler code
0641
Product ID
0641-1496_80a400d2-d293-4180-bfa7-7a8ce0734bc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA083312
Marketing category
ANDA
Marketing start
1973-09-19
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
50 mg/mL
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 HYDROCHLORIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992460, 992858

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-1496-31Promethazine Hydrochloride1 mL in 1 AMPULEINJECTION15
0641-1496-35Promethazine Hydrochloride25 in 1 PACKAGEINJECTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-1496-31ML - Milliliter0641-1496c081beed-7064-44b2-ae3e-5b034453696812012-07-24
0641-1496-35ML - Milliliter0641-1496356a6fa1-501c-4099-b031-6f5581d18a2212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
PHENOLINACTIVE INGREDIENT339NCG44TVPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-1496PROMETHAZINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20240412_13d9e59d-eadb-41d5-9f47-9c11a6efb31c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992858promethazine HCl 50 MG in 1 ML InjectionPSN744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a7
9928581 ML promethazine hydrochloride 50 MG/ML InjectionSCD744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a7
992858promethazine HCl 50 MG per 1 ML InjectionSY744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a7
992858promethazine HCl 50 MG in 1 ML InjectionPSNc525cb2c-9a01-4a9b-ad2c-08630719953d6
9928581 ML promethazine hydrochloride 50 MG/ML InjectionSCDc525cb2c-9a01-4a9b-ad2c-08630719953d6
992858promethazine HCl 50 MG per 1 ML InjectionSYc525cb2c-9a01-4a9b-ad2c-08630719953d6
992460promethazine HCl 25 MG in 1 ML InjectionPSN13d9e59d-eadb-41d5-9f47-9c11a6efb31c5
992858promethazine HCl 50 MG in 1 ML InjectionPSN13d9e59d-eadb-41d5-9f47-9c11a6efb31c5
9924601 ML promethazine hydrochloride 25 MG/ML InjectionSCD13d9e59d-eadb-41d5-9f47-9c11a6efb31c5
9928581 ML promethazine hydrochloride 50 MG/ML InjectionSCD13d9e59d-eadb-41d5-9f47-9c11a6efb31c5
992460promethazine HCl 25 MG per 1 ML InjectionSY13d9e59d-eadb-41d5-9f47-9c11a6efb31c5
992858promethazine HCl 50 MG per 1 ML InjectionSY13d9e59d-eadb-41d5-9f47-9c11a6efb31c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-1496-31006411496311 mL in 1 AMPULE1 mlHistorical
0641-1496-350064114963525 AMPULE in 1 PACKAGE (0641-1496-35) / 1 mL in 1 AMPULE (0641-1496-31) 25 ampule1973-09-190000-00-00NoNoCurrent