Home NDC 0603-7818 Nystatin
Product NDC 0603-7818
11-digit product format 006037818
Labeler code 0603
Product ID 0603-7818_62d0f1fd-d016-4396-b31d-8262b8a6521d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nystatin
Dosage form CREAM
Route TOPICAL
Labeler Par Pharmaceutical
Application ANDA065315
Marketing category ANDA
Marketing start 2006-05-31
Marketing end 2021-07-31
Substance NYSTATIN
Active strength 100000 [USP'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 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.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065315-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2006-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2006-05-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2006-05-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2006-05-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065315-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL 2006-05-31 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 SORBIC ACID INACTIVE INGREDIENT X045WJ989B NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [QUALITEST PHARMACEUTICALS] 4 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0603-7818-74 00603781874 1 TUBE in 1 CARTON (0603-7818-74) > 15 g in 1 TUBE 1 tube 2006-05-31 2021-07-31 No No Current 0603-7818-78 00603781878 1 TUBE in 1 CARTON (0603-7818-78) > 30 g in 1 TUBE 1 tube 2006-05-31 2021-07-31 No No Current 0603-7818-88 00603781888 1 TUBE in 1 CARTON (0603-7818-88) > 60 g in 1 TUBE 1 tube 2006-05-31 2021-07-31 No No Current