FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
68382-041
11-digit product format
683820041
Labeler code
68382
Product ID
68382-041_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
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
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
68382-041-01Promethazine Hydrochloride100 in 1 BOTTLETABLET1008
68382-041-05Promethazine Hydrochloride500 in 1 BOTTLETABLET5008
68382-041-10Promethazine Hydrochloride1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-041-01EA - Each68382-04116782f65-a21c-4a53-857c-9715cc63ccc212012-07-24
68382-041-05EA - Each68382-041e6ab47c3-786c-4ff6-bf66-8867bbe7303012022-11-07
68382-041-10EA - Each68382-041be2eca3b-e059-4a50-98b1-b5411c3020a512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]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 [H.J. HARKINS COMPANY, INC.]2
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-041PROMETHAZINE 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
992447promethazine HCl 25 MG Oral TabletPSN9e4e57fa-4ce3-4b7b-be5a-381801ed038621
992447promethazine hydrochloride 25 MG Oral TabletSCD9e4e57fa-4ce3-4b7b-be5a-381801ed038621
992447promethazine HCl 25 MG Oral TabletPSNa8fe4bc5-961b-4441-b8e2-ef93e4e137b610
992447promethazine hydrochloride 25 MG Oral TabletSCDa8fe4bc5-961b-4441-b8e2-ef93e4e137b610
992438promethazine HCl 12.5 MG Oral TabletPSNc0c0d4f0-8396-485b-a585-71df01491f6f8
992447promethazine HCl 25 MG Oral TabletPSN6aa6bfcc-024b-4ee2-a586-6c4ca879cea48
992447promethazine HCl 25 MG Oral TabletPSN69eea039-0098-4e2f-a832-152583b16f058
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 TabletSCD6aa6bfcc-024b-4ee2-a586-6c4ca879cea48
992447promethazine hydrochloride 25 MG Oral TabletSCD69eea039-0098-4e2f-a832-152583b16f058
992447promethazine hydrochloride 25 MG Oral TabletSCDc0c0d4f0-8396-485b-a585-71df01491f6f8
992475promethazine hydrochloride 50 MG Oral TabletSCDc0c0d4f0-8396-485b-a585-71df01491f6f8
992447promethazine HCl 25 MG Oral TabletPSNbae9c9c1-107f-0fcb-e053-2a95a90a75b27
992447promethazine HCl 25 MG Oral TabletPSNea490539-007b-47b1-bef9-22de02ae7c647
992447promethazine hydrochloride 25 MG Oral TabletSCDbae9c9c1-107f-0fcb-e053-2a95a90a75b27
992447promethazine hydrochloride 25 MG Oral TabletSCDea490539-007b-47b1-bef9-22de02ae7c647
992447promethazine HCl 25 MG Oral TabletPSN87429921-00d2-42c7-9e99-600e8075b8ce6
992447promethazine HCl 25 MG Oral TabletPSN84899861-8fed-536d-e053-2991aa0a42b26
992447promethazine HCl 25 MG Oral TabletPSN8749824b-6d66-430d-e053-2995a90a2db86
992447promethazine hydrochloride 25 MG Oral TabletSCD8749824b-6d66-430d-e053-2995a90a2db86
992447promethazine hydrochloride 25 MG Oral TabletSCD87429921-00d2-42c7-9e99-600e8075b8ce6
992447promethazine hydrochloride 25 MG Oral TabletSCD84899861-8fed-536d-e053-2991aa0a42b26
992447promethazine HCl 25 MG Oral TabletPSN891a74cf-c4df-975d-e053-2a95a90a68725
992447promethazine HCl 25 MG Oral TabletPSNb7137912-d119-4899-9c93-09c1c625f2905
992447promethazine HCl 25 MG Oral TabletPSN974208c8-4aad-4fb9-991b-cf30850342725
992447promethazine hydrochloride 25 MG Oral TabletSCD974208c8-4aad-4fb9-991b-cf30850342725
992447promethazine hydrochloride 25 MG Oral TabletSCD891a74cf-c4df-975d-e053-2a95a90a68725
992447promethazine hydrochloride 25 MG Oral TabletSCDb7137912-d119-4899-9c93-09c1c625f2905
992447promethazine HCl 25 MG Oral TabletPSNa4fbc2d8-19b3-4556-b0b9-6e7a14cd4c364
992447promethazine hydrochloride 25 MG Oral TabletSCDa4fbc2d8-19b3-4556-b0b9-6e7a14cd4c364
992438promethazine HCl 12.5 MG Oral TabletPSN4156e780-7ecf-bcae-e063-6394a90a2ae22
992447promethazine HCl 25 MG Oral TabletPSNf4c23037-e415-7604-e053-2995a90a5bb62
992447promethazine HCl 25 MG Oral TabletPSN01b3a05f-6002-4cf9-96ac-ff0eed8a196c2
992447promethazine HCl 25 MG Oral TabletPSNfe6294e3-2316-4efa-8be3-6e7e811589962
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 TabletSCD01b3a05f-6002-4cf9-96ac-ff0eed8a196c2
992447promethazine hydrochloride 25 MG Oral TabletSCDfe6294e3-2316-4efa-8be3-6e7e811589962
992447promethazine hydrochloride 25 MG Oral TabletSCDf4c23037-e415-7604-e053-2995a90a5bb62
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 TabletPSNb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992438promethazine HCl 12.5 MG Oral TabletPSN4d30e587-6d59-4cf5-ab45-c7639f759df91
992447promethazine HCl 25 MG Oral TabletPSN8d952b80-84c0-409a-901f-cb26818022b81
992447promethazine HCl 25 MG Oral TabletPSN26ba58b7-499e-8e22-e063-6394a90a1bfa1
992447promethazine HCl 25 MG Oral TabletPSNdcb1694a-8451-403c-b848-edb89ba170201
992447promethazine HCl 25 MG Oral TabletPSN4d30e587-6d59-4cf5-ab45-c7639f759df91
992447promethazine HCl 25 MG Oral TabletPSNb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992475promethazine HCl 50 MG Oral TabletPSN4d30e587-6d59-4cf5-ab45-c7639f759df91
992475promethazine HCl 50 MG Oral TabletPSNb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992438promethazine hydrochloride 12.5 MG Oral TabletSCD4d30e587-6d59-4cf5-ab45-c7639f759df91
992438promethazine hydrochloride 12.5 MG Oral TabletSCDb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992447promethazine hydrochloride 25 MG Oral TabletSCD4d30e587-6d59-4cf5-ab45-c7639f759df91
992447promethazine hydrochloride 25 MG Oral TabletSCDdcb1694a-8451-403c-b848-edb89ba170201
992447promethazine hydrochloride 25 MG Oral TabletSCD26ba58b7-499e-8e22-e063-6394a90a1bfa1
992447promethazine hydrochloride 25 MG Oral TabletSCDb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1
992447promethazine hydrochloride 25 MG Oral TabletSCD8d952b80-84c0-409a-901f-cb26818022b81
992475promethazine hydrochloride 50 MG Oral TabletSCD4d30e587-6d59-4cf5-ab45-c7639f759df91
992475promethazine hydrochloride 50 MG Oral TabletSCDb4985d9d-1aa0-4b36-bc98-6a5410ad9bad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-041-0168382004101100 TABLET in 1 BOTTLE (68382-041-01) 100 tablet2005-12-140000-00-00NoNoCurrent
68382-041-0568382004105500 TABLET in 1 BOTTLE (68382-041-05) 500 tablet2005-12-140000-00-00NoNoCurrent
68382-041-10683820041101000 TABLET in 1 BOTTLE (68382-041-10) 1000 tablet2005-12-140000-00-00NoNoCurrent