FDA.reportPublic FDA data

Nystatin

Product NDC
55154-4314
11-digit product format
551544314
Labeler code
55154
Product ID
55154-4314_c6dbde35-e0a0-4f55-be3e-471aeb0b0302
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA203621
Marketing category
ANDA
Marketing start
2020-07-17
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
ndc (product): 55154-4314
NystatinNYSTATINPAI Holdings, LLC dba PAI Pharma05a8b8b6-3639-47b8-b7fc-47b105f5e6f92024-07-16Adverse reactionsExact identifier
application applno (ANDA): 203621
application number: ANDA203621
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
56aca0e2-8691-4701-beba-e2315524709fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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
55154-4314-5Nystatin5 in 1 BAGSUSPENSION54
55154-4314-5Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4314NYSTATIN SUSPENSION [CARDINAL HEALTH 107, LLC]3Current NDC, 2 package rows20241025_56aca0e2-8691-4701-beba-e2315524709f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN56aca0e2-8691-4701-beba-e2315524709f4
312055nystatin 100000 UNT/ML Oral SuspensionSCD56aca0e2-8691-4701-beba-e2315524709f4
312055nystatin 100,000 UNT/ML Oral SuspensionSY56aca0e2-8691-4701-beba-e2315524709f4
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY56aca0e2-8691-4701-beba-e2315524709f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55154-4314-5551544314055 CUP, UNIT-DOSE in 1 BAG (55154-4314-5) / 5 mL in 1 CUP, UNIT-DOSE2023-08-01NoNoCurrent