Nystatin

Product NDC
60432-537
11-digit product format
604320537
Labeler code
60432
Product ID
60432-537_ae3ecbaa-1371-4b51-8abd-3a583c0de11b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA062512
Marketing category
ANDA
Marketing start
1995-04-15
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
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60432-537DDiscontinued by firm2026-08-17
excluded packagepackage60432-53760432-537-16DDiscontinued by firm2026-08-17
excluded packagepackage60432-53760432-537-60DDiscontinued 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 · 45 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 packagepackage60432-537-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60432-537-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-537-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-537-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-537-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-537-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-537-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-537-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-537-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-537-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-537-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-537-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-537-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-537-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-537-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-537-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60432-537-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60432-537-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60432-537-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60432-537-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60432-537-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60432-537-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60432-537-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60432-537-16557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage60432-537-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage60432-537-168af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage60432-537-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage60432-537-16834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage60432-537-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage60432-537-161332a3947898…d4bfe170f9cd…

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
A062512-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062512-001AA

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-293f01610625f2…
2019-09-15 20:21 UTC2019-09A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAARS1984-10-29e64feba35796…

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 06:07:402026-07A062512-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062512-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062512-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062512-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062512-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062512-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062512-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062512-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062512-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062512-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062512-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062512-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062512-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062512-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062512-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062512-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062512-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062512-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062512-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062512-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062512-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062512-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A062512-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062512-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062512-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062512-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A062512-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062512-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062512-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062512-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062512-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062512-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062512-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062512-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062512-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062512-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062512-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062512-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062512-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062512-001AA1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-537-16ML - Milliliter60432-5374cade063-c2f1-481b-8ce0-2f183b5989df12012-07-24
60432-537-60ML - Milliliter60432-537a627d2f6-c5a2-4e15-80fc-69e008e6482b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
alcoholINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
potassium phosphate, dibasicINACTIVE INGREDIENTCI71S98N1ZNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
sucroseINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
alcoholINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
potassium phosphate, dibasicINACTIVE INGREDIENTCI71S98N1ZNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
sucroseINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GNYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
potassium phosphate, dibasicINACTIVE INGREDIENTCI71S98N1ZNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
POTASSIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTCI71S98N1ZNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
potassium phosphate, dibasicINACTIVE INGREDIENTCI71S98N1ZNYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
sucroseINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
sucroseINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-537NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]4Legacy NDC20190124_d468395c-0f4c-4503-9a39-ae847524e683.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin Oral SuspensionNYSTATINXttrium Laboratories, Inc.4a670371-d373-1ba6-e063-6394a90a13b62026-02-06Adverse reactionsExact identifier
application applno (ANDA): 062512
application number: ANDA062512
NystatinNYSTATINA-S Medication Solutionse069d495-7f1a-4970-8f4d-aa93d124b3fc2023-02-04Adverse reactionsExact identifier
application applno (ANDA): 062512
application number: ANDA062512

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSNe069d495-7f1a-4970-8f4d-aa93d124b3fc9
312055nystatin 100000 UNT/ML Oral SuspensionSCDe069d495-7f1a-4970-8f4d-aa93d124b3fc9
312055nystatin 100,000 UNT/ML Oral SuspensionSYe069d495-7f1a-4970-8f4d-aa93d124b3fc9
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYe069d495-7f1a-4970-8f4d-aa93d124b3fc9
312055nystatin 100,000 UNT/mL Oral SuspensionPSN19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 100,000 UNT/mL Oral SuspensionPSNceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 100,000 UNT/mL Oral SuspensionPSNf7a98d15-ce46-4358-ac6e-d10afa4d34c21
312055nystatin 100000 UNT/ML Oral SuspensionSCD19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 100000 UNT/ML Oral SuspensionSCDceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 100000 UNT/ML Oral SuspensionSCDf7a98d15-ce46-4358-ac6e-d10afa4d34c21
312055nystatin 100,000 UNT/ML Oral SuspensionSY19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 100,000 UNT/ML Oral SuspensionSYceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 100,000 UNT/ML Oral SuspensionSYf7a98d15-ce46-4358-ac6e-d10afa4d34c21
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYf7a98d15-ce46-4358-ac6e-d10afa4d34c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-537-1660432053716473 mL in 1 BOTTLE, PLASTIC (60432-537-16) 473 ml1995-04-150000-00-00NoNoCurrent
60432-537-606043205376060 mL in 1 BOTTLE, GLASS (60432-537-60) 60 ml1995-04-150000-00-00NoNoCurrent