FDA.reportPublic FDA data

Nystatin

Product NDC
70166-331
11-digit product format
701660331
Labeler code
70166
Product ID
70166-331_7e97521f-a8f9-4bf7-e053-2991aa0a74e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Lohxa
Application
ANDA062876
Marketing category
ANDA
Marketing start
2019-01-03
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70166-331IInactivated by FDA2026-07-31
excluded packagepackage70166-33170166-331-05IInactivated by FDA2026-07-31

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
A062876-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORAL1988-02-29

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 22:54:322026-06A062876-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORAL1988-02-29a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70166-331-052024-01-30C16284748780-11030e365-5427-111a-e063-dadaa90a10e2Nystatin Oral Suspension, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70166-331-05Nystatin50 in 1 CARTONSUSPENSION501
70166-331-05Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70166-331NYSTATIN SUSPENSION [LOHXA]1Legacy NDC, 2 package rows20190104_a0540f97-18a2-4dd5-b3a8-a899c3831f51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSNa0540f97-18a2-4dd5-b3a8-a899c3831f511
312055nystatin 100000 UNT/ML Oral SuspensionSCDa0540f97-18a2-4dd5-b3a8-a899c3831f511
312055nystatin 100,000 UNT/ML Oral SuspensionSYa0540f97-18a2-4dd5-b3a8-a899c3831f511
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYa0540f97-18a2-4dd5-b3a8-a899c3831f511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70166-331-057016603310550 CUP, UNIT-DOSE in 1 CARTON (70166-331-05) > 5 mL in 1 CUP, UNIT-DOSE2019-01-030000-00-00NoNoCurrent