promethazine hydrochloride

Product NDC
57664-108
11-digit product format
576640108
Labeler code
57664
Product ID
57664-108_61563305-2f6b-e520-e053-2a91aa0a15c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA040863
Marketing category
ANDA
Marketing start
2009-01-27
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-108-18EA - Each57664-1089b4908a7-15e7-4044-944b-75f993be765112012-07-24
57664-108-88EA - Each57664-108e8838570-9254-4e8c-9df9-e8ee82895fc312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN1ec86d05-f8a6-684f-e054-00144ff88e882
992447promethazine HCl 25 MG Oral TabletPSN2ebb4414-e3f4-3d8d-e054-00144ff88e882
992447promethazine hydrochloride 25 MG Oral TabletSCD1ec86d05-f8a6-684f-e054-00144ff88e882
992447promethazine hydrochloride 25 MG Oral TabletSCD2ebb4414-e3f4-3d8d-e054-00144ff88e882
992438promethazine HCl 12.5 MG Oral TabletPSNff1dddab-72a0-4125-859e-554bece2d2b31
992447promethazine HCl 25 MG Oral TabletPSN2c5d4ccc-5d67-0329-e054-00144ff88e881
992447promethazine HCl 25 MG Oral TabletPSNff1dddab-72a0-4125-859e-554bece2d2b31
992475promethazine HCl 50 MG Oral TabletPSNff1dddab-72a0-4125-859e-554bece2d2b31
992438promethazine hydrochloride 12.5 MG Oral TabletSCDff1dddab-72a0-4125-859e-554bece2d2b31
992447promethazine hydrochloride 25 MG Oral TabletSCD2c5d4ccc-5d67-0329-e054-00144ff88e881
992447promethazine hydrochloride 25 MG Oral TabletSCDff1dddab-72a0-4125-859e-554bece2d2b31
992475promethazine hydrochloride 50 MG Oral TabletSCDff1dddab-72a0-4125-859e-554bece2d2b31