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USFDA APPLICATION NUMBER - 18164 / DOSAGE - TABLET;ORAL - EQ 500MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| naproxen sodium(UNII: 9TN87S3A3C) (naproxen - UNII:57Y76R9ATQ) | naproxen sodium | 550mg |
| naproxen(UNII: 57Y76R9ATQ) (naproxen - UNII:57Y76R9ATQ) | naproxen | 500mg | 375mg | 500mg |
Inactive Ingredients
| Ingredient Name | bryant ranch prepack | Dr. Reddy's Laboratories Inc. | Hikma Pharmaceutical | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC | NuCare Pharmaceuticals, Inc. | PD-Rx Pharmaceuticals, Inc. | Quality Care Products, LLC | REMEDYREPACK INC. | Teva Pharmaceuticals USA Inc | West-Ward Pharmaceuticals Corp | A-S Medication Solutions | Amneal Pharmaceuticals LLC | AvKARE, Inc. | Bryant Ranch Prepack | Genentech, Inc. | Major Pharmaceuticals | Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals, Inc. | REMEDYREPACK INC. | Unit Dose Services |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||||||||||||
| ferric oxide red(1K09F3G675) | |||||||||||||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||||||||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | |||||||||||||||||||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | |||||||||||||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||||||||||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||||||||
| methacrylic acid - methyl methacrylate copolymer (1:1)(74G4R6TH13) | |||||||||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||||||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | |||||||||||||||||||||
| POLYETHYLENE GLYCOL 6000(30IQX730WE) | |||||||||||||||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | |||||||||||||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||||||||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||||||||||||||||||||
| POLYVINYL ALCOHOL(532B59J990) | |||||||||||||||||||||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |||||||||||||||||||||
| POVIDONE K30(U725QWY32X) | |||||||||||||||||||||
| povidone K90(RDH86HJV5Z) | |||||||||||||||||||||
| povidone(FZ989GH94E) | |||||||||||||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | |||||||||||||||||||||
| POVIDONES(FZ989GH94E) | |||||||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||||||||
| sodium hydroxide(55X04QC32I) | |||||||||||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||||||||||
| TALC(7SEV7J4R1U) | |||||||||||||||||||||
| titanium dioxide(15FIX9V2JP) | |||||||||||||||||||||
| triethyl citrate(8Z96QXD6UM) | |||||||||||||||||||||
| water(059QF0KO0R) |
