Home NDC 42291-651 Nystatin
Product NDC 42291-651
11-digit product format 422910651
Labeler code 42291
Product ID 42291-651_3f165da9-403f-6f69-e063-6294a90a45bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA062506
Marketing category ANDA
Marketing start 2014-01-20
Substance NYSTATIN
Active strength 500000 [USP'U]/1
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 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 A062506-001 NYSTATIN NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062506-001 AA
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 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nystatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 500000 [USP'U]/1
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 312059 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-651-90 Nystatin 90 in 1 BOTTLE TABLET, FILM COATED 90 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-651 NYSTATIN TABLET, FILM COATED [AVKARE] 6 Current NDC, Legacy NDC, 1 package rows 20240111_8fd35f97-5405-2160-ca0f-35034ecd5a92.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42291-651-90 42291065190 90 TABLET, FILM COATED in 1 BOTTLE (42291-651-90) 2014-01-20 0000-00-00 No No Current