Nystatin

Product NDC
0374-5160
11-digit product format
003745160
Labeler code
0374
Product ID
0374-5160_6dea1fa4-ec98-9154-e053-2991aa0a91ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Lyne Laboratories, Inc.
Application
ANDA209082
Marketing category
ANDA
Marketing start
2018-07-16
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209082-001NYSTATINNYSTATIN100,000 UNITS/GMOINTMENT / TOPICALAT2018-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209082-001AT

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
2026-08-01 22:54:322026-06A209082-001NYSTATIN100,000 UNITS/GMOINTMENT / TOPICALAT2018-05-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209082-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYSTATINNYSTATINLeading Pharma, LLC8900ba02-2c6a-4dd4-b82f-45620c06e2552019-09-19Adverse reactionsExact identifier
application applno (ANDA): 209082
application number: ANDA209082