FDA.reportPublic FDA data

Nystatin

Product NDC
0121-1045
11-digit product format
001211045
Labeler code
0121
Product ID
0121-1045_4901e044-ed1c-4f55-add3-c33e1399f91a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA203621
Marketing category
ANDA
Marketing start
2024-06-21
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
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
A203621-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203621-001AA

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 22:54:322026-06A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203621-001AA1a50c72e98297…

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
NystatinNYSTATINPAI Holdings, LLC dba PAI Pharma28b4e26e-206a-4e8a-abfe-774b780e91c32026-07-21Adverse reactionsExact identifier
application applno (ANDA): 203621
application number: ANDA203621
NystatinNYSTATINCardinal Health 107, LLCd59098da-1395-49fb-9fd6-947bbbeed56f2026-02-26Adverse reactionsExact identifier
application applno (ANDA): 203621
application number: ANDA203621
NystatinNYSTATINMajor Pharmaceuticals17b9e33d-da9c-467a-bbc4-9e257727f19a2026-02-23Adverse reactionsExact identifier
application applno (ANDA): 203621
application number: ANDA203621
NystatinNYSTATINCardinal Health 107, LLC56aca0e2-8691-4701-beba-e2315524709f2025-10-23Adverse reactionsExact identifier
application applno (ANDA): 203621
application number: ANDA203621
NystatinNYSTATINPAI Holdings, LLC dba PAI Pharma05a8b8b6-3639-47b8-b7fc-47b105f5e6f92024-07-16Adverse reactionsExact identifier
application applno (ANDA): 203621
application number: ANDA203621
ndc (product): 0121-1045
NystatinNYSTATINAmerican Health Packagingd8c251a6-d4da-4664-bff4-6868541d11782024-02-22Adverse reactionsExact identifier
application applno (ANDA): 203621
application number: ANDA203621
NystatinNYSTATINA-S Medication Solutionscc3516cd-985c-489f-b4a1-8477876c5a972023-10-19Adverse reactionsExact identifier
application applno (ANDA): 203621
application number: ANDA203621
NystatinNYSTATINPharmaceutical Associates, Inc.31e3da10-5a7b-4bc5-8a4f-3e786b64c13a2022-01-13Adverse reactionsExact identifier
application applno (ANDA): 203621
application number: ANDA203621

Additional Listing Data#

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

Active Ingredients#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312055Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
05a8b8b6-3639-47b8-b7fc-47b105f5e6f9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1045-16Nystatin473 mL in 1 BOTTLESUSPENSION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1045-16ML - Milliliter0121-1045e343bae4-f68c-4ae6-bad6-4d96cd80952712024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1045NYSTATIN SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]1Current NDC, 1 package rows20240717_05a8b8b6-3639-47b8-b7fc-47b105f5e6f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN2e7fadda-5f16-4be6-b6bb-985fafe3a1f33
312055nystatin 100000 UNT/ML Oral SuspensionSCD2e7fadda-5f16-4be6-b6bb-985fafe3a1f33
312055nystatin 100,000 UNT/ML Oral SuspensionSY2e7fadda-5f16-4be6-b6bb-985fafe3a1f33
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY2e7fadda-5f16-4be6-b6bb-985fafe3a1f33
312055nystatin 100,000 UNT/mL Oral SuspensionPSN05a8b8b6-3639-47b8-b7fc-47b105f5e6f91
312055nystatin 100000 UNT/ML Oral SuspensionSCD05a8b8b6-3639-47b8-b7fc-47b105f5e6f91
312055nystatin 100,000 UNT/ML Oral SuspensionSY05a8b8b6-3639-47b8-b7fc-47b105f5e6f91
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY05a8b8b6-3639-47b8-b7fc-47b105f5e6f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-1045-1600121104516473 mL in 1 BOTTLE (0121-1045-16) 473 ml2024-06-21NoNoCurrent