NDC 0603-2435

Benztropine Mesylate

Benztropine Mesylate

Benztropine Mesylate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Benztropine Mesylate.

• Product ID: 0603-2435_25f6b524-02ce-4113-8779-188762d04663
• NDC: 0603-2435
• Product Type: Human Prescription Drug
• Proprietary Name: Benztropine Mesylate
• Generic Name: Benztropine Mesylate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2022-03-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040715
• Labeler Name: Par Pharmaceutical, Inc.
• Substance Name: BENZTROPINE MESYLATE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0603-2435-10

10 TABLET in 1 BOTTLE, PLASTIC (0603-2435-10)

• Marketing Start Date: 2022-03-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0603-2435-10 [00603243510]

Benztropine Mesylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA040715
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-08-27
• Marketing End Date: 2019-09-30

NDC 0603-2435-32 [00603243532]

Benztropine Mesylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA040715
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-08-27
• Marketing End Date: 2019-09-30

NDC 0603-2435-21 [00603243521]

Benztropine Mesylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA040715
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-08-27
• Marketing End Date: 2019-09-30

Drug Details

Active Ingredients

Ingredient	Strength
BENZTROPINE MESYLATE	2 mg/1

OpenFDA Data

• SPL SET ID: c19664aa-a797-4192-b5f3-e906a7cac048
• Manufacturer:
  • Qualitest Pharmaceuticals
• UNII:
  • WMJ8TL7510
• RxNorm Concept Unique ID - RxCUI:
  • 885209
  • 885219
  • 885213
• UPC Code:
  • 0306032434210
  • 0306032433213
  • 0306032435217

Pharmacological Class

• Anticholinergic [EPC]
• Antihistamine [EPC]
• Cholinergic Antagonists [MoA]
• Histamine Receptor Antagonists [MoA]

NDC Crossover Matching brand name "Benztropine Mesylate" or generic name "Benztropine Mesylate"

NDC	Brand Name	Generic Name
0143-9233	Benztropine Mesylate	Benztropine Mesylate
0143-9729	Benztropine Mesylate	Benztropine Mesylate
0517-0785	Benztropine Mesylate	Benztropine Mesylate
0603-2433	Benztropine Mesylate	benztropine mesylate
0603-2434	Benztropine Mesylate	benztropine mesylate
0603-2435	Benztropine Mesylate	benztropine mesylate
0603-2437	Benztropine Mesylate	benztropine mesylate
0603-2438	Benztropine Mesylate	benztropine mesylate
0603-2439	Benztropine Mesylate	benztropine mesylate
0615-2547	Benztropine Mesylate	Benztropine Mesylate
0615-2548	Benztropine Mesylate	Benztropine Mesylate
0615-2549	Benztropine Mesylate	Benztropine Mesylate
0615-7675	Benztropine Mesylate	Benztropine Mesylate
0615-7676	Benztropine Mesylate	benztropine mesylate
0615-7677	Benztropine Mesylate	benztropine mesylate
0615-8088	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
0615-8089	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
0615-8210	Benztropine Mesylate	benztropine mesylate
0615-8211	Benztropine Mesylate	benztropine mesylate
0615-8352	benztropine mesylate	benztropine mesylate
0832-1080	Benztropine Mesylate	benztropine mesylate
0832-1081	Benztropine Mesylate	benztropine mesylate
0832-1082	Benztropine Mesylate	benztropine mesylate
0904-6788	Benztropine Mesylate	benztropine mesylate
0904-6789	Benztropine Mesylate	benztropine mesylate
0904-6790	Benztropine Mesylate	benztropine mesylate
68084-381	Benztropine Mesylate	Benztropine Mesylate
68382-860	Benztropine Mesylate	Benztropine Mesylate
69097-826	Benztropine Mesylate	Benztropine Mesylate
69097-832	Benztropine Mesylate	Benztropine Mesylate
69097-827	Benztropine Mesylate	Benztropine Mesylate
69315-137	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
69315-136	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
69315-138	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
70518-0129	Benztropine Mesylate	Benztropine Mesylate
70518-0132	Benztropine Mesylate	Benztropine Mesylate
70518-0577	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
70518-0649	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
70518-0578	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
70518-0720	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
70518-1217	Benztropine Mesylate	Benztropine Mesylate
70518-0881	Benztropine Mesylate	Benztropine Mesylate
70518-1447	Benztropine Mesylate	Benztropine Mesylate
70518-1005	Benztropine Mesylate	Benztropine Mesylate
70518-1056	Benztropine Mesylate	Benztropine Mesylate
70518-1709	Benztropine Mesylate	Benztropine Mesylate
70518-1688	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
70518-1490	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
70518-1455	Benztropine Mesylate	Benztropine Mesylate
70518-1691	Benztropine Mesylate	Benztropine Mesylate