Home NDC 68308-152 Nystatin
Product NDC 68308-152
11-digit product format 683080152
Labeler code 68308
Product ID 68308-152_9bd397a3-24b8-4420-9adb-9917a8d6b233
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form POWDER
Route TOPICAL
Labeler Mayne Pharma Inc.
Application ANDA065203
Marketing category ANDA
Marketing start 2004-07-15
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 2023-12-31
Current FDA listing Historical FDA.report record 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 A065203-001 NYSTATIN NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065203-001 AT
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 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68308-152 NYSTATIN POWDER [MAYNE PHARMA INC.] 8 Legacy NDC 20221213_656fc23b-65af-465e-9bcb-67fbbfa9b84e.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 · 1 matching rows.
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 68308-152-15 68308015215 15 g in 1 BOTTLE, PLASTIC (68308-152-15) 15 g 2004-07-15 0000-00-00 No No Current 68308-152-30 68308015230 30 g in 1 BOTTLE, PLASTIC (68308-152-30) 30 g 2004-07-15 0000-00-00 No No Current 68308-152-60 68308015260 60 g in 1 BOTTLE, PLASTIC (68308-152-60) 60 g 2004-07-15 0000-00-00 No No Current