Home NDC 72578-130-01 Mupirocin
Product NDC 72578-130
Requested package NDC 72578-130-01
11-digit product format 725780130
Labeler code 72578
Product ID 72578-130_a8cfad1c-cbde-492b-935a-5b362bafe3ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mupirocin
Dosage form CREAM
Route TOPICAL
Labeler Viona Pharmaceuticals Inc
Application ANDA218361
Marketing category ANDA
Marketing start 2026-10-10
Substance MUPIROCIN CALCIUM
Active strength 20 mg/g
Pharmacologic classes RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A218361-001 MUPIROCIN CALCIUM MUPIROCIN CALCIUM EQ 2% BASE CREAM / TOPICAL AB 2026-09-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218361-001 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 2026-10-15 13:18:30 2026-09 A218361-001 MUPIROCIN CALCIUM EQ 2% BASE CREAM / TOPICAL AB 2026-09-29 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A218361-001 AB 1 c2088c7a36db…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mupirocin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MUPIROCIN CALCIUM 20 mg/g
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72578-130-01 72578013001 1 TUBE in 1 CARTON (72578-130-01) / 15 g in 1 TUBE 1 tube 2026-10-10 No No Current