Home NDC 42291-618 MINOXIDIL
Product NDC 42291-618
11-digit product format 422910618
Labeler code 42291
Product ID 42291-618_48e97f58-ac9b-0967-e063-6294a90a26a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name minoxidil
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA072708
Marketing category ANDA
Marketing start 2013-08-01
Substance MINOXIDIL
Active strength 2.5 mg/1
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog .
Additional Listing Data#
Finished product Yes
Brand name base MINOXIDIL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5965120SH1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197986 Internal RxNorm lookup 197987 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-618-01 MINOXIDIL 100 in 1 BOTTLE TABLET 100 13 42291-618-90 MINOXIDIL 90 in 1 BOTTLE TABLET 90 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded minoxidil ACTIVE INGREDIENT 5965120SH1 MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] 2 minoxidil ACTIVE MOIETY 5965120SH1 MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] 2 Anhydrous Lactose INACTIVE INGREDIENT 3SY5LH9PMK MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] 2 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] 2 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] 2 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] 2 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-618 MINOXIDIL TABLET [AVKARE] 12 Current NDC, Legacy NDC, 2 package rows 20250112_02d7399f-94cc-f718-f214-587301edd138.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 Marketing end Sample Exclude flag Status 42291-618-01 42291061801 100 TABLET in 1 BOTTLE (42291-618-01) 100 tablet 2013-08-01 0000-00-00 No No Current 42291-618-90 42291061890 90 in 1 BOTTLE Historical