Home NDC 0009-4544 Detrol
Product NDC 0009-4544
11-digit product format 000094544
Labeler code 0009
Product ID 0009-4544_75d531d1-9683-4809-ab23-7f7872928085
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tolterodine tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pharmacia & Upjohn Company LLC
Application NDA020771
Marketing category NDA
Marketing start 1998-03-25
Marketing end 0000-00-00
Substance TOLTERODINE TARTRATE
Active strength 2 mg/1
Pharmacologic classes Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020771-001 DETROL TOLTERODINE TARTRATE 1MG TABLET / ORAL AB RLD 1998-03-25 N020771-002 DETROL TOLTERODINE TARTRATE 2MG TABLET / ORAL AB RLD, RS 1998-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOLTERODINE TARTRATE ACTIVE INGREDIENT 5T619TQR3R DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 11 TOLTERODINE ACTIVE MOIETY WHE7A56U7K DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 11 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 11 TOLTERODINE TARTRATE ACTIVE INGREDIENT 5T619TQR3R DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 1 TOLTERODINE ACTIVE MOIETY WHE7A56U7K DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-4544 DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [PHARMACIA & UPJOHN COMPANY LLC] 16 Legacy NDC 20240806_42f819c9-4108-4ca7-92c5-a213037dd4db.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0009-4544-02 00009454402 60 TABLET, FILM COATED in 1 BOTTLE (0009-4544-02) 1998-03-25 0000-00-00 No No Current 0009-4544-03 00009454403 500 TABLET, FILM COATED in 1 BOTTLE (0009-4544-03) 1998-03-25 0000-00-00 No No Current