Home NDC 0093-0983 Nystatin
Product NDC 0093-0983
11-digit product format 000930983
Labeler code 0093
Product ID 0093-0983_b55205c3-f0be-44eb-a267-3af07c1639f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA062506
Marketing category ANDA
Marketing start 1990-09-30
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0093-0983 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0093-0983 0093-0983-99 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 0093-0983-99 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 0093-0983-99 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 0093-0983-99 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 0093-0983-99 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 0093-0983-99 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 0093-0983-99 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 0093-0983-99 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 0093-0983-99 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0093-0983-99 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0093-0983-99 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0093-0983-99 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0093-0983-99 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0093-0983-99 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 0093-0983-99 50b4072663b7…eae3003ed65e…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-0983-01 Nystatin 100 in 1 BOTTLE TABLET, FILM COATED 100 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 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 0093-0983 NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 12 Current NDC, Legacy NDC, 1 package rows 20240207_f03b294d-10cd-4bba-92c8-42ae9b110cd0.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 0093-0983-01 00093098301 100 TABLET, FILM COATED in 1 BOTTLE (0093-0983-01) 1990-09-30 0000-00-00 No No Current 0093-0983-99 00093098399 681818 TABLET, FILM COATED in 1 PAIL (0093-0983-99) 23-JUN-23 Current