Nystatin

Product NDC
17856-0811
Requested package NDC
17856-0811-7
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-081117856-0811-7IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 4 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-081117856-0811-7IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-081117856-0811-7IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-081117856-0811-7IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-081117856-0811-7IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-073f01610625f2…
2019-09-15 20:21 UTC2019-09A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203621-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA2016-01-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203621-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203621-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203621-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203621-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203621-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203621-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203621-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203621-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203621-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203621-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203621-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203621-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203621-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203621-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203621-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203621-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203621-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203621-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203621-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203621-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203621-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A203621-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203621-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203621-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203621-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A203621-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203621-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203621-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203621-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203621-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203621-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203621-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203621-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203621-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203621-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203621-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203621-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203621-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203621-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203621-001AA1cb3db0bc1861…

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#

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
17856-0811-717856081107120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-7) > 2 mL in 1 SYRINGE120 syringe2021-01-260000-00-00NoNoCurrent