NDC 0378-3402

Tolterodine Tartrate

Tolterodine Tartrate

Tolterodine Tartrate is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Tolterodine Tartrate.

• Product ID: 0378-3402_03852abe-992e-4d0b-a105-19ca8faba01e
• NDC: 0378-3402
• Product Type: Human Prescription Drug
• Proprietary Name: Tolterodine Tartrate
• Generic Name: Tolterodine Tartrate
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-10-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201486
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: TOLTERODINE TARTRATE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-3402-05

500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3402-05)

• Marketing Start Date: 2013-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-3402-05 [00378340205]

Tolterodine Tartrate CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA201486
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-10-31

NDC 0378-3402-93 [00378340293]

Tolterodine Tartrate CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA201486
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-10-31

NDC 0378-3402-77 [00378340277]

Tolterodine Tartrate CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA201486
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-10-31
• Marketing End Date: 2016-04-25

Drug Details

Active Ingredients

Ingredient	Strength
TOLTERODINE TARTRATE	2 mg/1

OpenFDA Data

• SPL SET ID: 7f3f6571-3234-42fd-ac5b-dba97714b399
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 5T619TQR3R
• RxNorm Concept Unique ID - RxCUI:
  • 855189
  • 855182
• UPC Code:
  • 0303783402932
  • 0303783404936

Pharmacological Class

• Cholinergic Muscarinic Antagonist [EPC]
• Cholinergic Muscarinic Antagonists [MoA]
• Cholinergic Muscarinic Antagonist [EPC]
• Cholinergic Muscarinic Antagonists [MoA]

NDC Crossover Matching brand name "Tolterodine Tartrate" or generic name "Tolterodine Tartrate"

NDC	Brand Name	Generic Name
0093-0010	Tolterodine Tartrate	Tolterodine Tartrate
0093-0018	Tolterodine Tartrate	Tolterodine Tartrate
0093-2049	Tolterodine Tartrate	Tolterodine Tartrate
0093-2050	Tolterodine Tartrate	Tolterodine Tartrate
0093-2055	Tolterodine Tartrate	Tolterodine Tartrate
0093-2056	Tolterodine Tartrate	Tolterodine Tartrate
0093-7163	Tolterodine Tartrate	Tolterodine Tartrate
0093-7164	Tolterodine Tartrate	Tolterodine Tartrate
0378-3402	Tolterodine Tartrate	Tolterodine Tartrate
0378-3404	Tolterodine Tartrate	Tolterodine Tartrate
0904-6592	TOLTERODINE TARTRATE	TOLTERODINE
0904-6593	TOLTERODINE TARTRATE	TOLTERODINE
10135-706	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE
10135-707	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE
13668-189	TOLTERODINE TARTRATE	TOLTERODINE
68151-3549	Tolterodine Tartrate	Tolterodine Tartrate
68151-4247	Tolterodine Tartrate	Tolterodine Tartrate
68151-4281	Tolterodine Tartrate	Tolterodine Tartrate
70518-1416	Tolterodine Tartrate	Tolterodine Tartrate
70518-1873	Tolterodine Tartrate	Tolterodine Tartrate
71610-002	Tolterodine Tartrate	Tolterodine Tartrate
13668-190	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE
31722-608	Tolterodine Tartrate	Tolterodine Tartrate
31722-607	Tolterodine Tartrate	Tolterodine Tartrate
33342-098	Tolterodine tartrate	Tolterodine tartrate
33342-097	Tolterodine tartrate	Tolterodine tartrate
43353-346	Tolterodine Tartrate	Tolterodine Tartrate
50090-3475	Tolterodine Tartrate	Tolterodine Tartrate
51079-197	Tolterodine Tartrate	Tolterodine Tartrate
51079-198	Tolterodine Tartrate	Tolterodine Tartrate
59762-0800	Tolterodine Tartrate	Tolterodine Tartrate
60429-825	Tolterodine Tartrate	Tolterodine Tartrate
60429-826	Tolterodine Tartrate	Tolterodine Tartrate
59762-0170	Tolterodine Tartrate	Tolterodine Tartrate
60687-319	Tolterodine Tartrate	Tolterodine Tartrate
60687-330	Tolterodine Tartrate	Tolterodine Tartrate
71205-319	Tolterodine Tartrate	Tolterodine Tartrate
43975-322	Tolterodine Tartrate	Tolterodine Tartrate
43975-323	Tolterodine Tartrate	Tolterodine Tartrate
0009-4541	Detrol	tolterodine tartrate
0009-4544	Detrol	tolterodine tartrate
0009-5190	Detrol LA	tolterodine tartrate
0009-5191	Detrol LA	tolterodine tartrate