Home NDC 0121-4785 Nystatin
Product NDC 0121-4785
11-digit product format 001214785
Labeler code 0121
Product ID 0121-4785_7f6f191e-0969-4d20-8189-e65fb74bad39
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Pharmaceutical Associates, Inc.
Application ANDA062512
Marketing category ANDA
Marketing start 2009-06-01
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 100000 [USP'U]/mL
Pharmacologic classes Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 2 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0121-4785-35 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0121-4785-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0121-4785-35 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0121-4785-05 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0121-4785-35 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0121-4785-05 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0121-4785-35 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0121-4785-05 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0121-4785-35 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0121-4785-05 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0121-4785-35 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0121-4785-05 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0121-4785-35 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0121-4785-05 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0121-4785-35 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0121-4785-05 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0121-4785-35 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0121-4785-05 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0121-4785-35 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0121-4785-05 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0121-4785-35 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0121-4785-05 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0121-4785-35 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0121-4785-05 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0121-4785-35 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0121-4785-05 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0121-4785-35 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0121-4785-05 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0121-4785-35 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0121-4785-05 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0121-4785-05 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0121-4785-35 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0121-4785-05 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0121-4785-35 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0121-4785-05 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0121-4785-35 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0121-4785-05 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0121-4785-35 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0121-4785-05 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0121-4785-35 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…
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 A062512-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062512-001 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 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 POTASSIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT CI71S98N1Z NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2
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.