FDA.reportPublic FDA data

Ammonium lactate

Product NDC
70771-1988
Requested package NDC
70771-1988-6
11-digit product format
707711988
Labeler code
70771
Product ID
70771-1988_2fba2d8c-f152-49fd-88bf-2cec6a189264
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonium lactate
Dosage form
CREAM
Route
TOPICAL
Labeler
Zydus Lifesciences Limited
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217815-001AMMONIUM LACTATEAMMONIUM LACTATEEQ 12% BASECREAM / TOPICALAB2026-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217815-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217815-001AMMONIUM LACTATEEQ 12% BASECREAM / TOPICALAB2026-02-1284e616aacf4f…
2026-08-18 06:07:402026-07A217815-001AMMONIUM LACTATEEQ 12% BASECREAM / TOPICALAB2026-02-12caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217815-001AMMONIUM LACTATEEQ 12% BASECREAM / TOPICALAB2026-02-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217815-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A217815-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217815-001AB1a50c72e98297…

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
IngredientStrength
AMMONIUM LACTATE120 mg/g

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ammonium lactateAMMONIUM LACTATEZydus Lifesciences Limited10a894e6-d23a-4142-8c9f-7bf96be9b9912026-10-02Exact identifier
application applno (ANDA): 217815
application number: ANDA217815
ndc (package): 70771-1988-6
ndc (product): 70771-1988
ndc11 (package): 70771198806

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1988-6707711988062 TUBE in 1 CARTON (70771-1988-6) / 140 g in 1 TUBE (70771-1988-5) 2 tube2026-10-02NoNoCurrent