NDC 0085-1366

TEMODAR

Temozolomide

TEMODAR is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Temozolomide.

• Product ID: 0085-1366_1230129b-4a56-46c4-b4e8-512870a4ff5b
• NDC: 0085-1366
• Product Type: Human Prescription Drug
• Proprietary Name: TEMODAR
• Generic Name: Temozolomide
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1999-08-11
• Marketing Category: NDA / NDA
• Application Number: NDA021029
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: TEMOZOLOMIDE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0085-1366-03

5 PACKET in 1 CARTON (0085-1366-03) > 1 CAPSULE in 1 PACKET (0085-1366-05)

• Marketing Start Date: 1999-08-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0085-1366-01 [00085136601]

TEMODAR CAPSULE

• Marketing Category: NDA
• Application Number: NDA021029
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-08-11
• Marketing End Date: 2015-05-29

NDC 0085-1366-02 [00085136602]

TEMODAR CAPSULE

• Marketing Category: NDA
• Application Number: NDA021029
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-08-11
• Marketing End Date: 2015-05-29

NDC 0085-1366-04 [00085136604]

TEMODAR CAPSULE

• Marketing Category: NDA
• Application Number: NDA021029
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-08-11

NDC 0085-1366-03 [00085136603]

TEMODAR CAPSULE

• Marketing Category: NDA
• Application Number: NDA021029
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-08-11

NDC 0085-1366-05 [00085136605]

TEMODAR CAPSULE

• Marketing Category: NDA
• Application Number: NDA021029
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-11-02

Drug Details

Active Ingredients

Ingredient	Strength
TEMOZOLOMIDE	100 mg/1

OpenFDA Data

• SPL SET ID: 046a9011-3911-4d3f-a15f-fbb56d5aad56
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • YF1K15M17Y
• RxNorm Concept Unique ID - RxCUI:
  • 700883
  • 313209
  • 700885
  • 705619
  • 705617
  • 313210
  • 261288
  • 317160
  • 835945
  • 261289
  • 261290
  • 261291
  • 313211
  • 835948

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0085-1366	TEMODAR	Temozolomide
0085-1381	TEMODAR	Temozolomide
0085-1417	TEMODAR	Temozolomide
0085-1425	TEMODAR	Temozolomide
0085-1430	TEMODAR	Temozolomide
0085-1519	TEMODAR	Temozolomide
0085-3004	TEMODAR	Temozolomide
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