FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
68382-040
11-digit product format
683820040
Labeler code
68382
Product ID
68382-040_d461a206-0842-428f-ad9b-a4aac8193fe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA040596
Marketing category
ANDA
Marketing start
2005-12-14
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
12.5 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 HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992438, 992447, 992475

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
68382-040-01Promethazine Hydrochloride100 in 1 BOTTLETABLET1008
68382-040-05Promethazine Hydrochloride500 in 1 BOTTLETABLET5008
68382-040-10Promethazine Hydrochloride1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-040-01EA - Each68382-040521292de-e6dc-4496-b4d6-546b6818517012012-07-24
68382-040-10EA - Each68382-0401f2a47a4-1ee7-4760-b548-681386d0a51b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]4
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-040PROMETHAZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 3 package rows20231110_c0c0d4f0-8396-485b-a585-71df01491f6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992438promethazine HCl 12.5 MG Oral TabletPSNda246971-20b8-b46e-8366-9700d3604cf11023
992438promethazine hydrochloride 12.5 MG Oral TabletSCDda246971-20b8-b46e-8366-9700d3604cf11023
992438promethazine HCl 12.5 MG Oral TabletPSNadb04635-584f-4fef-98ca-2574be312a7310
992438promethazine hydrochloride 12.5 MG Oral TabletSCDadb04635-584f-4fef-98ca-2574be312a7310
992438promethazine HCl 12.5 MG Oral TabletPSNc0c0d4f0-8396-485b-a585-71df01491f6f8
992447promethazine HCl 25 MG Oral TabletPSNc0c0d4f0-8396-485b-a585-71df01491f6f8
992475promethazine HCl 50 MG Oral TabletPSNc0c0d4f0-8396-485b-a585-71df01491f6f8
992438promethazine hydrochloride 12.5 MG Oral TabletSCDc0c0d4f0-8396-485b-a585-71df01491f6f8
992447promethazine hydrochloride 25 MG Oral TabletSCDc0c0d4f0-8396-485b-a585-71df01491f6f8
992475promethazine hydrochloride 50 MG Oral TabletSCDc0c0d4f0-8396-485b-a585-71df01491f6f8
992438promethazine HCl 12.5 MG Oral TabletPSN4156e780-7ecf-bcae-e063-6394a90a2ae22
992447promethazine HCl 25 MG Oral TabletPSN4156e780-7ecf-bcae-e063-6394a90a2ae22
992475promethazine HCl 50 MG Oral TabletPSN4156e780-7ecf-bcae-e063-6394a90a2ae22
992438promethazine hydrochloride 12.5 MG Oral TabletSCD4156e780-7ecf-bcae-e063-6394a90a2ae22
992447promethazine hydrochloride 25 MG Oral TabletSCD4156e780-7ecf-bcae-e063-6394a90a2ae22
992475promethazine hydrochloride 50 MG Oral TabletSCD4156e780-7ecf-bcae-e063-6394a90a2ae22
992438promethazine HCl 12.5 MG Oral TabletPSN65b2f396-666b-4b08-890f-19429844e74b1
992438promethazine HCl 12.5 MG Oral TabletPSNb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992438promethazine HCl 12.5 MG Oral TabletPSN4d30e587-6d59-4cf5-ab45-c7639f759df91
992447promethazine HCl 25 MG Oral TabletPSNb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992447promethazine HCl 25 MG Oral TabletPSN4d30e587-6d59-4cf5-ab45-c7639f759df91
992475promethazine HCl 50 MG Oral TabletPSN65b2f396-666b-4b08-890f-19429844e74b1
992475promethazine HCl 50 MG Oral TabletPSNb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992475promethazine HCl 50 MG Oral TabletPSN4d30e587-6d59-4cf5-ab45-c7639f759df91
992438promethazine hydrochloride 12.5 MG Oral TabletSCDb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992438promethazine hydrochloride 12.5 MG Oral TabletSCD4d30e587-6d59-4cf5-ab45-c7639f759df91
992438promethazine hydrochloride 12.5 MG Oral TabletSCD65b2f396-666b-4b08-890f-19429844e74b1
992447promethazine hydrochloride 25 MG Oral TabletSCD4d30e587-6d59-4cf5-ab45-c7639f759df91
992447promethazine hydrochloride 25 MG Oral TabletSCDb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992475promethazine hydrochloride 50 MG Oral TabletSCD4d30e587-6d59-4cf5-ab45-c7639f759df91
992475promethazine hydrochloride 50 MG Oral TabletSCDb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992475promethazine hydrochloride 50 MG Oral TabletSCD65b2f396-666b-4b08-890f-19429844e74b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-040-0168382004001100 TABLET in 1 BOTTLE (68382-040-01) 100 tablet2005-12-140000-00-00NoNoCurrent
68382-040-0568382004005500 TABLET in 1 BOTTLE (68382-040-05) 500 tablet2005-12-140000-00-00NoNoCurrent
68382-040-10683820040101000 TABLET in 1 BOTTLE (68382-040-10) 1000 tablet2005-12-140000-00-00NoNoCurrent