FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
0591-5319
11-digit product format
005915319
Labeler code
0591
Product ID
0591-5319_4ad005c9-31b6-4232-995f-920d1839256e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA083711
Marketing category
ANDA
Marketing start
1973-09-21
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992447, 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
0591-5319-012024-02-06C16284748780-11030e365-392e-111a-e063-dadaa90a10e2Promethazine Hydrochloride Tablets USP Revised: December 2016 Rx Only
0591-5319-012024-01-30C16284748780-11030e365-392e-111a-e063-dadaa90a10e2Promethazine Hydrochloride Tablets USP Revised: December 2016 Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5319-01Promethazine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5319-01EA - Each0591-5319cf6d8984-3767-4393-95e6-89d64d3b4b1212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]4
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5319PROMETHAZINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]8Current NDC, Legacy NDC, 1 package rows20240207_a32255f0-0077-489e-bdc6-869aca8cd434.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSNa32255f0-0077-489e-bdc6-869aca8cd4348
992475promethazine HCl 50 MG Oral TabletPSNa32255f0-0077-489e-bdc6-869aca8cd4348
992447promethazine hydrochloride 25 MG Oral TabletSCDa32255f0-0077-489e-bdc6-869aca8cd4348
992475promethazine hydrochloride 50 MG Oral TabletSCDa32255f0-0077-489e-bdc6-869aca8cd4348

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5319-000059153190032000 TABLET in 1 BAG (0591-5319-00)32000 tablet21-SEP-73Current
0591-5319-0100591531901100 TABLET in 1 BOTTLE, PLASTIC (0591-5319-01) 100 tablet1973-09-210000-00-00NoNoCurrent
0591-5319-770059153197738712 TABLET in 1 CONTAINER (0591-5319-77)38712 tablet19-SEP-24Current