NDC 43975-252

TEMOZOLOMIDE

Temozolomide

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

• Product ID: 43975-252_138d1a7f-8cd9-4e00-9fd2-2235c0d67a18
• NDC: 43975-252
• Product Type: Human Prescription Drug
• Proprietary Name: TEMOZOLOMIDE
• Generic Name: Temozolomide
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203490
• Labeler Name: ANI Pharmaceuticals, Inc.
• Substance Name: TEMOZOLOMIDE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 43975-252-05

5 CAPSULE in 1 BOTTLE, GLASS (43975-252-05)

• Marketing Start Date: 2016-07-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43975-252-05 [43975025205]

Temozolomide CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA203490
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-13

NDC 43975-252-14 [43975025214]

Temozolomide CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA203490
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-13

Drug Details

Active Ingredients

Ingredient	Strength
TEMOZOLOMIDE	5 mg/1

OpenFDA Data

• SPL SET ID: 604da6f4-e0ef-4c99-8165-18adbcd8ba1f
• Manufacturer:
  • Amerigen Pharmaceuticals Inc.
• UNII:
  • YF1K15M17Y
• RxNorm Concept Unique ID - RxCUI:
  • 700883
  • 313209
  • 700885
  • 313210
  • 313211
  • 317160
• UPC Code:
  • 0343975253058
  • 0343975256059
  • 0343975254055
  • 0343975257056
  • 0343975252051

Pharmacological Class

• Alkylating Activity [MoA]
• Alkylating Drug [EPC]

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

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