Home NDC 0378-3404-05 Tolterodine Tartrate
Product NDC 0378-3404
Requested package NDC 0378-3404-05
11-digit product format 003783404
Labeler code 0378
Product ID 0378-3404_03852abe-992e-4d0b-a105-19ca8faba01e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolterodine Tartrate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA201486
Marketing category ANDA
Marketing start 2013-10-31
Marketing end 0000-00-00
Substance TOLTERODINE TARTRATE
Active strength 4 mg/1
Pharmacologic classes Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201486-001 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL 2013-10-31 A201486-002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL 2013-10-31
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A201486-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL 2013-10-31 a50c72e98297…2026-08-01 22:54:32 2026-06 A201486-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL 2013-10-31 a50c72e98297…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOLTERODINE TARTRATE ACTIVE INGREDIENT 5T619TQR3R TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 TOLTERODINE ACTIVE MOIETY WHE7A56U7K TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] 3 TOLTERODINE TARTRATE ACTIVE INGREDIENT 5T619TQR3R TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 TOLTERODINE ACTIVE MOIETY WHE7A56U7K TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-3404-05 00378340405 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3404-05) 2013-10-31 0000-00-00 No No Current