FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
10702-003
11-digit product format
107020003
Labeler code
10702
Product ID
10702-003_4ceccb65-dd65-461c-e063-6294a90afcda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA040712
Marketing category
ANDA
Marketing start
2006-07-31
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROMETHAZINE HYDROCHLORIDE
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-003-012024-02-09C16284748780-11030e365-66e8-111a-e063-dadaa90a10e2PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-003-102024-02-09C16284748780-11030e365-66e8-111a-e063-dadaa90a10e2PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-003-502024-02-09C16284748780-11030e365-66e8-111a-e063-dadaa90a10e2PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-003-012024-01-30C16284748780-11030e365-66e8-111a-e063-dadaa90a10e2PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-003-102024-01-30C16284748780-11030e365-66e8-111a-e063-dadaa90a10e2PROMETHAZINE HYDROCHLORIDE TABLETS, USP
10702-003-502024-01-30C16284748780-11030e365-66e8-111a-e063-dadaa90a10e2PROMETHAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-003-01PROMETHAZINE HYDROCHLORIDE100 in 1 BOTTLETABLET10013
10702-003-10PROMETHAZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET100013
10702-003-50PROMETHAZINE HYDROCHLORIDE500 in 1 BOTTLETABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-003-01EA - Each10702-003b8596f90-204c-4a9b-b79e-93017c05ea8d12013-02-13
10702-003-10EA - Each10702-003e84c4693-921a-4cd4-b21e-4378aa9290f512013-02-13
10702-003-50EA - Each10702-003664b0cb3-029e-40bc-949f-0476704da3e612016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
METHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JPROMETHAZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]8
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]4
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JPROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]4
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JPROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
METHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JPROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-003PROMETHAZINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]12Current NDC, Legacy NDC, 3 package rows20240502_7a137adf-39b7-4b14-80da-c3cac9ad562a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSNe6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488103
992447promethazine hydrochloride 25 MG Oral TabletSCDe6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488103
992447promethazine HCl 25 MG Oral TabletPSN5ce082e9-13eb-4e63-a9e2-657d3ef0e9f834
992447promethazine hydrochloride 25 MG Oral TabletSCD5ce082e9-13eb-4e63-a9e2-657d3ef0e9f834
992438promethazine HCl 12.5 MG Oral TabletPSN7a137adf-39b7-4b14-80da-c3cac9ad562a13
992447promethazine HCl 25 MG Oral TabletPSN7a137adf-39b7-4b14-80da-c3cac9ad562a13
992475promethazine HCl 50 MG Oral TabletPSN7a137adf-39b7-4b14-80da-c3cac9ad562a13
992438promethazine hydrochloride 12.5 MG Oral TabletSCD7a137adf-39b7-4b14-80da-c3cac9ad562a13
992447promethazine hydrochloride 25 MG Oral TabletSCD7a137adf-39b7-4b14-80da-c3cac9ad562a13
992475promethazine hydrochloride 50 MG Oral TabletSCD7a137adf-39b7-4b14-80da-c3cac9ad562a13
992447promethazine HCl 25 MG Oral TabletPSN2c9a4767-23c4-4a1c-bb4c-2bad1351c27010
992447promethazine hydrochloride 25 MG Oral TabletSCD2c9a4767-23c4-4a1c-bb4c-2bad1351c27010
992438promethazine HCl 12.5 MG Oral TabletPSN857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992447promethazine HCl 25 MG Oral TabletPSN857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992438promethazine hydrochloride 12.5 MG Oral TabletSCD857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992447promethazine hydrochloride 25 MG Oral TabletSCD857dd0a8-3e23-423c-9b5e-9a8779b4c7d09
992447promethazine HCl 25 MG Oral TabletPSN40d4ef22-f12f-0667-e054-00144ff8d46c6
992447promethazine hydrochloride 25 MG Oral TabletSCD40d4ef22-f12f-0667-e054-00144ff8d46c6
992447promethazine HCl 25 MG Oral TabletPSN29a8b172-1bad-40db-8d73-1fe7fb309cff5
992447promethazine HCl 25 MG Oral TabletPSNb96904e7-cc67-4abc-b946-8423f3f897ff5
992447promethazine hydrochloride 25 MG Oral TabletSCD29a8b172-1bad-40db-8d73-1fe7fb309cff5
992447promethazine hydrochloride 25 MG Oral TabletSCDb96904e7-cc67-4abc-b946-8423f3f897ff5
992447promethazine HCl 25 MG Oral TabletPSN804e2525-d61f-7bed-e053-2991aa0a5daa4
992447promethazine hydrochloride 25 MG Oral TabletSCD804e2525-d61f-7bed-e053-2991aa0a5daa4
992447promethazine HCl 25 MG Oral TabletPSNa7b1e8b2-6f20-4096-87c7-cf349ed4f7b93
992447promethazine HCl 25 MG Oral TabletPSNd9cb1a44-d646-d9e9-e053-2995a90a24ff3
992447promethazine HCl 25 MG Oral TabletPSNc8b6d06b-1468-4ff5-bf76-813abb5a093f3
992447promethazine HCl 25 MG Oral TabletPSNb54439a3-1d01-4c5f-8508-731790ae215b3
992447promethazine HCl 25 MG Oral TabletPSN7e5715cf-056f-4095-e053-2991aa0ad3e53
992447promethazine HCl 25 MG Oral TabletPSN6bcaa89f-5f14-dc45-e053-2a91aa0aac543
992447promethazine hydrochloride 25 MG Oral TabletSCDa7b1e8b2-6f20-4096-87c7-cf349ed4f7b93
992447promethazine hydrochloride 25 MG Oral TabletSCDb54439a3-1d01-4c5f-8508-731790ae215b3
992447promethazine hydrochloride 25 MG Oral TabletSCD6bcaa89f-5f14-dc45-e053-2a91aa0aac543
992447promethazine hydrochloride 25 MG Oral TabletSCDc8b6d06b-1468-4ff5-bf76-813abb5a093f3
992447promethazine hydrochloride 25 MG Oral TabletSCDd9cb1a44-d646-d9e9-e053-2995a90a24ff3
992447promethazine hydrochloride 25 MG Oral TabletSCD7e5715cf-056f-4095-e053-2991aa0ad3e53
992447promethazine HCl 25 MG Oral TabletPSN96b4ab0d-abcf-409a-872e-b69611ebecca2
992447promethazine HCl 25 MG Oral TabletPSN4f681538-7ac4-484c-9e6d-b571d73b9e0b2
992447promethazine hydrochloride 25 MG Oral TabletSCD96b4ab0d-abcf-409a-872e-b69611ebecca2
992447promethazine hydrochloride 25 MG Oral TabletSCD4f681538-7ac4-484c-9e6d-b571d73b9e0b2
992447promethazine HCl 25 MG Oral TabletPSN7df0a51f-ea74-754b-e053-2991aa0a5e6c1
992447promethazine hydrochloride 25 MG Oral TabletSCD7df0a51f-ea74-754b-e053-2991aa0a5e6c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-003-0110702000301100 TABLET in 1 BOTTLE (10702-003-01) 100 tablet2006-07-310000-00-00NoNoCurrent
10702-003-10107020003101000 TABLET in 1 BOTTLE (10702-003-10) 1000 tablet2006-07-310000-00-00NoNoCurrent
10702-003-5010702000350500 TABLET in 1 BOTTLE (10702-003-50) 500 tablet2016-05-190000-00-00NoNoCurrent