Home NDC 70771-1874 Ketoconazole
Product NDC 70771-1874
11-digit product format 707711874
Labeler code 70771
Product ID 70771-1874_9795147c-bca9-481c-b910-edee5bdd5f29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketoconazole
Dosage form SHAMPOO
Route TOPICAL
Labeler Zydus Lifesciences Limited
Application ANDA218559
Marketing category ANDA
Marketing start 2025-03-08
Substance KETOCONAZOLE
Active strength 20 mg/mL
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 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 A218559-001 KETOCONAZOLE KETOCONAZOLE 2% SHAMPOO / TOPICAL AB 2025-03-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218559-001 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 A218559-001 KETOCONAZOLE 2% SHAMPOO / TOPICAL AB 2025-03-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218559-001 KETOCONAZOLE 2% SHAMPOO / TOPICAL AB 2025-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218559-001 KETOCONAZOLE 2% SHAMPOO / TOPICAL AB 2025-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218559-001 KETOCONAZOLE 2% SHAMPOO / TOPICAL AB 2025-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218559-001 KETOCONAZOLE 2% SHAMPOO / TOPICAL AB 2025-03-07 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218559-001 KETOCONAZOLE 2% SHAMPOO / TOPICAL AB 2025-03-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ketoconazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOCONAZOLE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R9400W927I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106336 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70771-1874-7 Ketoconazole 120 mL in 1 BOTTLE SHAMPOO 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1874 KETOCONAZOLE SHAMPOO [ZYDUS LIFESCIENCES LIMITED] 2 Current NDC, 1 package rows 20250315_c004ee91-558a-450b-9e4e-d11ab9d28054.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 Units Marketing start Sample Exclude flag Status 70771-1874-7 70771187407 120 mL in 1 BOTTLE (70771-1874-7) 120 ml 2025-03-08 No No Current