Home NDC 72578-203 Ammonium lactate
Product NDC 72578-203
11-digit product format 725780203
Labeler code 72578
Product ID 72578-203_17a76f6b-e86b-478f-8cec-7fbebfdb489b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ammonium lactate
Dosage form CREAM
Route TOPICAL
Labeler Viona Pharmaceuticals Inc
Application ANDA217815
Marketing category ANDA
Marketing start 2026-10-02
Substance AMMONIUM LACTATE
Active strength 120 mg/g
Pharmacologic classes Acidifying Activity [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 43 .
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 A217815-001 AMMONIUM LACTATE AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2026-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217815-001 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 2026-09-14 22:38:34 2026-08 A217815-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2026-02-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217815-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2026-02-12 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217815-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2026-02-12 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A217815-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217815-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217815-001 AB 1 a50c72e98297…
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 Ammonium lactate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMMONIUM LACTATE 120 mg/g
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72578-203-10 72578020310 2 TUBE in 1 CARTON (72578-203-10) / 140 g in 1 TUBE (72578-203-13) 2 tube 2026-10-02 No No Current 72578-203-11 72578020311 385 g in 1 BOTTLE (72578-203-11) 385 g 2026-10-02 No No Current