Home NDC 74157-012 Halcinonide Topical Solution
Product NDC 74157-012
11-digit product format 741570012
Labeler code 74157
Product ID 74157-012_2cda4c71-2cf3-26b6-e063-6294a90a8530
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Halcinonide Topical
Dosage form SOLUTION
Route TOPICAL
Labeler INA Pharmaceutics Inc
Application ANDA217671
Marketing category ANDA
Marketing start 2025-01-29
Substance HALCINONIDE
Active strength 1 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 A217671-001 HALCINONIDE HALCINONIDE 0.1% SOLUTION / TOPICAL AT RS 2024-05-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217671-001 AT
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 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL AT RS 2024-05-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL AT RS 2024-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL AT RS 2024-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL RS 2024-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL 2024-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL 2024-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL 2024-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL 2024-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL 2024-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL 2024-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL 2024-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL 2024-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL 2024-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL 2024-05-29 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217671-001 HALCINONIDE 0.1% SOLUTION / TOPICAL AT RS 2024-05-29 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A217671-001 AT 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217671-001 AT 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217671-001 AT 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217671-001 AT 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Halcinonide Topical Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALCINONIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SI86V6QNEG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310669 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 74157-012-12 Halcinonide Topical Solution 1 in 1 CARTON SOLUTION 1 1 74157-012-12 Halcinonide Topical Solution 120 mL in 1 BOTTLE, PLASTIC SOLUTION 120 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 74157-012 HALCINONIDE TOPICAL SOLUTION (HALCINONIDE TOPICAL) SOLUTION [INA PHARMACEUTICS INC] 1 Current NDC, 2 package rows 20250201_debd165b-118b-4ef0-af7d-3b90a8fd8ded.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 74157-012-12 74157001212 1 BOTTLE, PLASTIC in 1 CARTON (74157-012-12) / 120 mL in 1 BOTTLE, PLASTIC 2025-01-29 No No Current