Home NDC 50383-667 Lidocaine and Prilocaine
Product NDC 50383-667
11-digit product format 503830667
Labeler code 50383
Product ID 50383-667_9edd385f-7517-4fba-8c12-923bd080283c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine and Prilocaine
Dosage form CREAM
Route TOPICAL
Labeler Akorn
Application ANDA076290
Marketing category ANDA
Marketing start 2003-09-25
Marketing end 0000-00-00
Substance LIDOCAINE; PRILOCAINE
Active strength 25 mg/g; mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIDOCAINE ACTIVE INGREDIENT 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 PRILOCAINE ACTIVE INGREDIENT 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 PRILOCAINE ACTIVE MOIETY 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE AND PRILOCAINE CREAM [HI-TECH PHARMACAL CO., INC.] 7 LIDOCAINE ACTIVE INGREDIENT 98PI200987 RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 PRILOCAINE ACTIVE INGREDIENT 046O35D44R RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 LIDOCAINE ACTIVE MOIETY 98PI200987 RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 PRILOCAINE ACTIVE MOIETY 046O35D44R RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 WATER INACTIVE INGREDIENT 059QF0KO0R RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 LIDOCAINE ACTIVE INGREDIENT 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 LIDOCAINE ACTIVE INGREDIENT 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 PRILOCAINE ACTIVE INGREDIENT 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 PRILOCAINE ACTIVE INGREDIENT 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 PRILOCAINE ACTIVE MOIETY 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 PRILOCAINE ACTIVE MOIETY 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE AND PRILOCAINE CREAM [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-667 LIDOCAINE AND PRILOCAINE CREAM [AKORN] 12 Legacy NDC 20220528_9378d186-5b25-49bc-8563-a659fa1194c2.zip 50383-667 RELADOR PAK PLUS (LIDOCAINE AND PRILOCAINE) KIT [ACCELIS PHARMA] 2 Legacy NDC 20150710_466cc21b-bed1-41a8-ae34-af71c698ccc3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-667-15 50383066715 1 TUBE in 1 CARTON (50383-667-15) > 15 g in 1 TUBE 1 tube 2003-09-25 0000-00-00 No No Current 50383-667-30 50383066730 1 TUBE in 1 CARTON (50383-667-30) > 30 g in 1 TUBE 1 tube 2003-09-25 0000-00-00 No No Current