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USFDA APPLICATION NUMBER - 18163 / DOSAGE - CAPSULE;ORAL - 7.5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| TEMAZEPAM(UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS) | TEMAZEPAM | 7.5mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions LLC | American Health Packaging | Bryant Ranch Prepack | Liberty Pharmaceuticals, Inc. | Preferred Pharmaceuticals, Inc | REMEDYREPACK INC. | Cardinal Health | KAISER FOUNDATION HOSPITALS | Qualitest Pharmaceuticals | Aphena Pharma Solutions - Tennessee, LLC | AvKARE, Inc. | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC | A-S Medication Solutions | Mylan Institutional Inc. | Mylan Pharmaceuticals Inc. | Proficient Rx LP |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | |||||||||||||||||
| AMMONIA(5138Q19F1X) | |||||||||||||||||
| anhydrous lactose(3SY5LH9PMK) | |||||||||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||||||||||
| D&C RED NO. 28(767IP0Y5NH) | |||||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||||||
| EDETATE DISODIUM(7FLD91C86K) | |||||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | |||||||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||||||||
| gelatin(2G86QN327L) | |||||||||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | |||||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||||||
| LACTOSE(J2B2A4N98G) | |||||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||||||||
| potassium hydroxide(WZH3C48M4T) | |||||||||||||||||
| POWDERED CELLULOSE(SMD1X3XO9M) | |||||||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||||||||
| SHELLAC(46N107B71O) | |||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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