FDA.reportPublic FDA data

Nystatin

Product NDC
17856-0811
11-digit product format
178560811
Labeler code
17856
Product ID
17856-0811_964869a5-8615-4c0d-9051-8a90a1270b88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA203621
Marketing category
ANDA
Marketing start
2019-05-07
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
2022-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0811IInactivated by FDA2026-08-03
excluded packagepackage17856-081117856-0811-1IInactivated by FDA2026-08-03
excluded packagepackage17856-081117856-0811-2IInactivated by FDA2026-08-03
excluded packagepackage17856-081117856-0811-3IInactivated by FDA2026-08-03
excluded packagepackage17856-081117856-0811-4IInactivated by FDA2026-08-03
excluded packagepackage17856-081117856-0811-5IInactivated by FDA2026-08-03
excluded packagepackage17856-081117856-0811-6IInactivated by FDA2026-08-03
excluded packagepackage17856-081117856-0811-7IInactivated by FDA2026-08-03

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
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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
17856-0811-12023-01-30C16284748780-1f386c649-c1ab-0266-e053-dadaa90a7c1aNystatin Oral Suspension USP [100,000 units per mL]
17856-0811-22023-01-30C16284748780-1f386c649-c1ab-0266-e053-dadaa90a7c1aNystatin Oral Suspension USP [100,000 units per mL]
17856-0811-32023-01-30C16284748780-1f386c649-c1ab-0266-e053-dadaa90a7c1aNystatin Oral Suspension USP [100,000 units per mL]
17856-0811-42023-01-30C16284748780-1f386c649-c1ab-0266-e053-dadaa90a7c1aNystatin Oral Suspension USP [100,000 units per mL]
17856-0811-52023-01-30C16284748780-1f386c649-c1ab-0266-e053-dadaa90a7c1aNystatin Oral Suspension USP [100,000 units per mL]
17856-0811-62023-01-30C16284748780-1f386c649-c1ab-0266-e053-dadaa90a7c1aNystatin Oral Suspension USP [100,000 units per mL]
17856-0811-72023-01-30C16284748780-1f386c649-c1ab-0266-e053-dadaa90a7c1aNystatin Oral Suspension USP [100,000 units per mL]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0811-1Nystatin0.5 mL in 1 SYRINGESUSPENSION0.53
17856-0811-1Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-0811-2Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-0811-2Nystatin1 mL in 1 SYRINGESUSPENSION13
17856-0811-3Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-0811-3Nystatin2 mL in 1 SYRINGESUSPENSION23
17856-0811-4Nystatin48 in 1 BOX, UNIT-DOSESUSPENSION483
17856-0811-4Nystatin5 mL in 1 SYRINGESUSPENSION53
17856-0811-5Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION53
17856-0811-5Nystatin72 in 1 BOX, UNIT-DOSESUSPENSION723
17856-0811-6Nystatin1 mL in 1 SYRINGESUSPENSION13
17856-0811-6Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-0811-7Nystatin120 in 1 BOX, UNIT-DOSESUSPENSION1203
17856-0811-7Nystatin2 mL in 1 SYRINGESUSPENSION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0811NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 14 package rows20210128_378c70ef-0fbc-4f0d-89c6-200735282fd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN378c70ef-0fbc-4f0d-89c6-200735282fd73
312055nystatin 100000 UNT/ML Oral SuspensionSCD378c70ef-0fbc-4f0d-89c6-200735282fd73
312055nystatin 100,000 UNT/ML Oral SuspensionSY378c70ef-0fbc-4f0d-89c6-200735282fd73
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY378c70ef-0fbc-4f0d-89c6-200735282fd73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0811-117856081101120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-1) > .5 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent
17856-0811-217856081102120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-2) > 1 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent
17856-0811-317856081103120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-3) > 2 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent
17856-0811-41785608110448 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-4) > 5 mL in 1 SYRINGE48 syringe2021-01-260000-00-00NoNoCurrent
17856-0811-51785608110572 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0811-5) > 5 mL in 1 CUP, UNIT-DOSE2021-01-260000-00-00NoNoCurrent
17856-0811-617856081106120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-6) > 1 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent
17856-0811-717856081107120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-7) > 2 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent