Nystatin

Product NDC
0904-6456
11-digit product format
009046456
Labeler code
0904
Product ID
0904-6456_8c6b5207-d7d1-4e01-b271-35b57bce8ca8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
Major Pharmaceuticals
Application
ANDA065138
Marketing category
ANDA
Marketing start
2015-02-15
Marketing end
2019-04-29
Substance
NYSTATIN
Active strength
100000 U/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-6456DDiscontinued by firm2026-08-17
excluded packagepackage0904-64560904-6456-02DDiscontinued by firm2026-08-17
excluded packagepackage0904-64560904-6456-31DDiscontinued by firm2026-08-17
excluded packagepackage0904-64560904-6456-36DDiscontinued by firm2026-08-17

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-6456-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-6456-36d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-6456-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6456-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6456-36f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6456-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6456-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6456-362ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6456-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6456-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6456-36a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6456-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6456-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6456-36cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6456-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6456-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6456-36cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6456-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6456-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6456-36302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6456-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6456-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6456-36ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6456-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6456-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6456-360efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6456-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6456-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6456-36ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6456-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6456-31367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6456-36367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6456-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6456-31557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6456-36557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6456-02557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065138-001NYSTATINNYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065138-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-233f01610625f2…
2019-09-15 20:21 UTC2019-09A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065138-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065138-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065138-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065138-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065138-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065138-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065138-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065138-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065138-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065138-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065138-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065138-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065138-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065138-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065138-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065138-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065138-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065138-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065138-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065138-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065138-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065138-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A065138-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065138-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065138-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065138-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A065138-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065138-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065138-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065138-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065138-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065138-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065138-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065138-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065138-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065138-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065138-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065138-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065138-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065138-001AT1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6456-02GM - Gram0904-6456e0afc34a-24fa-4997-8d95-e096c349d23412015-03-03
0904-6456-31GM - Gram0904-6456590ec48f-f796-414f-9223-166bedc67f0412015-03-03
0904-6456-36GM - Gram0904-64562d08cba7-2156-4934-a53e-b76acf8d718012015-03-03