NDC 16571-818

TEMOZOLOMIDE

Temozolomide

TEMOZOLOMIDE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is Temozolomide.

Product ID16571-818_97b882a4-22e6-4de7-8770-24b3fdab2938
NDC16571-818
Product TypeHuman Prescription Drug
Proprietary NameTEMOZOLOMIDE
Generic NameTemozolomide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-10-04
Marketing CategoryANDA /
Application NumberANDA206309
Labeler NameRising Pharmaceuticals, Inc.
Substance NameTEMOZOLOMIDE
Active Ingredient Strength100 mg/1
Pharm ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 16571-818-02

20 CAPSULE in 1 BOTTLE (16571-818-02)
Marketing Start Date2022-10-04
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "TEMOZOLOMIDE" or generic name "Temozolomide"

NDCBrand NameGeneric Name
0054-0320TemozolomideTemozolomide
0054-0321TemozolomideTemozolomide
0054-0322TemozolomideTemozolomide
0054-0323TemozolomideTemozolomide
0054-0324TemozolomideTemozolomide
0054-0325TemozolomideTemozolomide
0093-7599TemozolomideTemozolomide
0093-7600TemozolomideTemozolomide
67877-537TemozolomideTemozolomide
67877-539TemozolomideTemozolomide
67877-540TemozolomideTemozolomide
67877-541TemozolomideTemozolomide
67877-542TemozolomideTemozolomide
67877-538TemozolomideTemozolomide
68382-751temozolomidetemozolomide
68382-753temozolomidetemozolomide
68382-756temozolomidetemozolomide
68382-754temozolomidetemozolomide
68382-755temozolomidetemozolomide
68382-752temozolomidetemozolomide
70771-1096temozolomidetemozolomide
70771-1092temozolomidetemozolomide
70771-1094temozolomidetemozolomide
70771-1095temozolomidetemozolomide
70771-1097temozolomidetemozolomide
70771-1093temozolomidetemozolomide
0781-2694TemozolomideTemozolomide
0781-2691TemozolomideTemozolomide
0781-2692TemozolomideTemozolomide
0781-2696TemozolomideTemozolomide
0781-2695TemozolomideTemozolomide
0781-2693TemozolomideTemozolomide
0093-7602TemozolomideTemozolomide
0093-7639TemozolomideTemozolomide
16729-130TemozolomideTemozolomide
16729-049TemozolomideTemozolomide
16729-050TemozolomideTemozolomide
0093-7601TemozolomideTemozolomide
0093-7638TemozolomideTemozolomide
16729-129TemozolomideTemozolomide
16729-051TemozolomideTemozolomide
16729-048TemozolomideTemozolomide
42737-101TEMOZOLOMIDETEMOZOLOMIDE
42737-103TEMOZOLOMIDETEMOZOLOMIDE
42737-106TEMOZOLOMIDETEMOZOLOMIDE
42737-104TEMOZOLOMIDETEMOZOLOMIDE
42737-102TEMOZOLOMIDETEMOZOLOMIDE
42737-105TEMOZOLOMIDETEMOZOLOMIDE
43975-252TEMOZOLOMIDETEMOZOLOMIDE
43975-256TEMOZOLOMIDETEMOZOLOMIDE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.