NDC 10135-588

Loxapine

Loxapine Succinate

Loxapine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Loxapine Succinate.

Product ID10135-588_42bcc296-c005-416f-b0ad-2dccc0c8fe46
NDC10135-588
Product TypeHuman Prescription Drug
Proprietary NameLoxapine
Generic NameLoxapine Succinate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA090695
Labeler NameMarlex Pharmaceuticals Inc
Substance NameLOXAPINE SUCCINATE
Active Ingredient Strength50 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 10135-588-10

1000 TABLET in 1 BOTTLE (10135-588-10)
Marketing Start Date2014-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-588-10 [10135058810]

Loxapine TABLET
Marketing CategoryANDA
Application NumberANDA090695
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01
Inactivation Date2020-01-31

NDC 10135-588-01 [10135058801]

Loxapine TABLET
Marketing CategoryANDA
Application NumberANDA090695
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LOXAPINE SUCCINATE50 mg/1

OpenFDA Data

SPL SET ID:dee2537b-1bd8-42f6-990f-62359e646822
Manufacturer
UNII

NDC Crossover Matching brand name "Loxapine" or generic name "Loxapine Succinate"

NDCBrand NameGeneric Name
0378-7005Loxapineloxapine
0378-7010Loxapineloxapine
0378-7025Loxapineloxapine
0378-7050Loxapineloxapine
0527-1394LoxapineLoxapine
0527-1395LoxapineLoxapine
0527-1396LoxapineLoxapine
0527-1397LoxapineLoxapine
0591-0369LoxapineLoxapine
0591-0370LoxapineLoxapine
0591-0371LoxapineLoxapine
0591-0372LoxapineLoxapine
10135-585LoxapineLoxapine succinate
10135-586LoxapineLoxapine succinate
10135-587LoxapineLoxapine succinate
10135-588LoxapineLoxapine succinate
17856-1397LoxapineLoxapine
35573-436LoxapineLoxapine
35573-437LoxapineLoxapine
35573-438LoxapineLoxapine
35573-439LoxapineLoxapine
50090-3099LoxapineLoxapine
50090-3457Loxapineloxapine
50090-4701LoxapineLoxapine
51079-901Loxapineloxapine
68151-2875LoxapineLoxapine
70518-0283LoxapineLoxapine
70518-0347LoxapineLoxapine
70518-0416LoxapineLoxapine
70518-0995LoxapineLoxapine
70518-0346LoxapineLoxapine
70518-1681LoxapineLoxapine
70518-1896LoxapineLoxapine
70518-1792LoxapineLoxapine
51079-902LoxapineLoxapine
51079-903LoxapineLoxapine
70518-2120LoxapineLoxapine
10885-003Adasuveloxapine
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