nystatin

Product NDC
68788-9247
11-digit product format
687889247
Labeler code
68788
Product ID
68788-9247_f5d79b2a-e2de-4c03-9287-6f99f5f78a7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA062129
Marketing category
ANDA
Marketing start
2014-11-13
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9247DDiscontinued by firm2026-08-03
excluded packagepackage68788-924768788-9247-1DDiscontinued by firm2026-08-03
excluded packagepackage68788-924768788-9247-3DDiscontinued by firm2026-08-03

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
A062129-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062129-001AT

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 UTC2026-02A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982cb3db0bc1861…

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 UTC2026-02A062129-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062129-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062129-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062129-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062129-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062129-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062129-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062129-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062129-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062129-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062129-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062129-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062129-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062129-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062129-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062129-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062129-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062129-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062129-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062129-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062129-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A062129-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062129-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062129-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062129-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A062129-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062129-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062129-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062129-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062129-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062129-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062129-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062129-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062129-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062129-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062129-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062129-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062129-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062129-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062129-001AT1cb3db0bc1861…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
nystatinACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
AlgeldrateINACTIVE INGREDIENT03J11K103CNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
EthylenediamineINACTIVE INGREDIENT60V9STC53FNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
PEG-8 StearateINACTIVE INGREDIENT2P9L47VI5ENYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Sorbic AcidINACTIVE INGREDIENTX045WJ989BNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1