Home NDC 0374-5160 Nystatin
Product NDC 0374-5160
11-digit product format 003745160
Labeler code 0374
Product ID 0374-5160_6dea1fa4-ec98-9154-e053-2991aa0a91ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin Ointment
Dosage form OINTMENT
Route TOPICAL
Labeler Lyne Laboratories, Inc.
Application ANDA209082
Marketing category ANDA
Marketing start 2018-07-16
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 2019-12-31
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 A209082-001 NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209082-001 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 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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.