Home NDC 72162-2496 Nystatin
Product NDC 72162-2496
11-digit product format 721622496
Labeler code 72162
Product ID 72162-2496_89ed46f6-8777-46e7-b60f-f1372031cf66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form CREAM
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA213566
Marketing category ANDA
Marketing start 2021-08-25
Substance NYSTATIN
Active strength 100000 [USP'U]/g
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A213566-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213566-001 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.
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 2026-10-15 13:18:30 2026-09 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nystatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BDF1O1C72E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 543546 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2496 NYSTATIN CREAM [BRYANT RANCH PREPACK] 100 Current NDC, 4 package rows 20250523_b6aa24e6-1acb-4fd3-9ec7-11b1a69c1598.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-2496-2 72162249602 1 TUBE in 1 CARTON (72162-2496-2) / 15 g in 1 TUBE 1 tube 2025-05-15 No No Current 72162-2496-3 72162249603 1 TUBE in 1 CARTON (72162-2496-3) / 30 g in 1 TUBE 1 tube 2025-05-15 No No Current