Nystatin

Product NDC
17856-0811
Requested package NDC
17856-0811-4
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-081117856-0811-4IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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…

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 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
17856-0811-41785608110448 SYRINGE in 1 BOX, UNIT-DOSE (17856-0811-4) > 5 mL in 1 SYRINGE48 syringe2021-01-260000-00-00NoNoCurrent