Home NDC 70685-001 Ketoconazole
Product NDC 70685-001
11-digit product format 706850001
Labeler code 70685
Product ID 70685-001_ba8ac2cf-fc6e-465e-84b9-518a041bfa5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketoconazole
Dosage form TABLET
Route ORAL
Labeler Esjay Pharma LLC
Application ANDA219129
Marketing category ANDA
Marketing start 2025-09-10
Substance KETOCONAZOLE
Active strength 200 mg/1
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 70685-001-02 excluded package package 70685-001-03 excluded package package 70685-001-01
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219129-001 KETOCONAZOLE KETOCONAZOLE 200MG TABLET / ORAL AB 2025-07-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219129-001 AB
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 2026-08-18 06:07:40 2026-07 A219129-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2025-07-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219129-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2025-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219129-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2025-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219129-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2025-07-03 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219129-001 KETOCONAZOLE 200MG TABLET / ORAL AB 2025-07-03 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70685-001-01 Ketoconazole 30 in 1 BOTTLE TABLET 30 2 70685-001-02 Ketoconazole 100 in 1 BOTTLE TABLET 100 2 70685-001-03 Ketoconazole 500 in 1 BOTTLE TABLET 500 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70685-001-01 70685000101 30 TABLET in 1 BOTTLE (70685-001-01) 30 tablet 2025-09-10 No No Historical 70685-001-02 70685000102 100 TABLET in 1 BOTTLE (70685-001-02) 100 tablet 2025-09-10 No No Historical 70685-001-03 70685000103 500 TABLET in 1 BOTTLE (70685-001-03) 500 tablet 2025-09-10 No No Historical