FDA.reportPublic FDA data

Nystop

Product NDC
71335-2869
11-digit product format
713352869
Labeler code
71335
Product ID
71335-2869_5574b64c-6a0e-4eea-828f-26d7b6fb91ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA064118
Marketing category
ANDA
Marketing start
1996-08-16
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A064118-001NYSTOPNYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT1996-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064118-001AT

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 22:54:322026-06A064118-001NYSTOP100,000 UNITS/GMPOWDER / TOPICALAT1996-08-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A064118-001AT1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystopNYSTATINBryant Ranch Prepack0bb31239-fb77-442a-a9ee-ba61b45e7e682026-07-14Adverse reactionsExact identifier
application applno (ANDA): 064118
application number: ANDA064118
NystopNYSTATINBryant Ranch Prepack64041bdf-1207-47f6-93f3-bc4656a7d2ae2025-10-21Adverse reactionsExact identifier
application applno (ANDA): 064118
application number: ANDA064118
NystopNYSTATINBryant Ranch Prepackaffea013-4f09-4e7d-a696-9f501d379af62025-10-21Adverse reactionsExact identifier
application applno (ANDA): 064118
application number: ANDA064118
ndc (product): 71335-2869
NystatinNYSTATINNorthstar Rx LLC9e6d0b0d-a68f-46aa-a707-3110ecb931b42025-09-30Adverse reactionsExact identifier
application applno (ANDA): 064118
application number: ANDA064118
NystopNYSTATINBryant Ranch Prepack69ebb4dd-f45d-448d-97cd-3f89354939752025-08-26Adverse reactionsExact identifier
application applno (ANDA): 064118
application number: ANDA064118
NystopNYSTATINPadagis US LLCe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f2024-10-31Adverse reactionsExact identifier
application applno (ANDA): 064118
application number: ANDA064118
NystopNYSTATINBryant Ranch Prepack87175864-9877-4e80-b870-907abb8ac2892024-03-22Adverse reactionsExact identifier
application applno (ANDA): 064118
application number: ANDA064118
NystopNYSTATINBryant Ranch Prepack5bce98a3-2964-4edc-b8da-8a46dafadf5e2024-01-11Adverse reactionsExact identifier
application applno (ANDA): 064118
application number: ANDA064118

Additional Listing Data#

Finished product
Yes
Brand name base
Nystop
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BDF1O1C72EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
261178Internal RxNorm lookup
646456Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
affea013-4f09-4e7d-a696-9f501d379af6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2869-1Nystop30 g in 1 BOTTLE, PLASTICPOWDER30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2869-1GM - Gram71335-28698519d6bb-0394-4d2a-a5ed-af175c6bbe7c12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSNaffea013-4f09-4e7d-a696-9f501d379af6100
261178NYSTOP 100,000 UNT/GM Topical PowderPSNaffea013-4f09-4e7d-a696-9f501d379af6100
261178nystatin 100 UNT/MG Topical Powder [Nystop]SBDaffea013-4f09-4e7d-a696-9f501d379af6100
646456nystatin 100 UNT/MG Topical PowderSCDaffea013-4f09-4e7d-a696-9f501d379af6100
646456nystatin 100,000 UNT/GM Topical PowderSYaffea013-4f09-4e7d-a696-9f501d379af6100
261178Nystop 100 UNT/MG Topical PowderSYaffea013-4f09-4e7d-a696-9f501d379af6100
261178Nystop 100,000 UNT/GM Topical PowderSYaffea013-4f09-4e7d-a696-9f501d379af6100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2869-17133528690130 g in 1 BOTTLE, PLASTIC (71335-2869-1) 30 g2025-10-21NoNoCurrent