Home NDC 17856-0538 Nystatin
Product NDC 17856-0538
11-digit product format 178560538
Labeler code 17856
Product ID 17856-0538_8a722d13-c10b-4cfd-b1cc-ae0cdb9e4236
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA062512
Marketing category ANDA
Marketing start 1995-04-15
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 · 68 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 package package 17856-0538-9 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17856-0538-6 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17856-0538-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17856-0538-5 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17856-0538-8 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17856-0538-7 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17856-0538-9 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17856-0538-6 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17856-0538-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17856-0538-5 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17856-0538-8 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17856-0538-7 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…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 17856-0538-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-0538-7 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-0538-9 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-0538-8 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-0538-5 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-0538-6 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 17856-0538-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0538-7 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0538-9 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0538-8 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0538-5 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0538-6 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 17856-0538-7 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-0538-9 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-0538-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-0538-8 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-0538-5 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-0538-6 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 17856-0538-7 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-0538-9 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-0538-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-0538-8 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-0538-5 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-0538-6 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 17856-0538-7 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-0538-9 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-0538-1 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-0538-8 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-0538-5 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-0538-6 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 17856-0538-7 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 17856-0538-9 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 17856-0538-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 17856-0538-8 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 17856-0538-5 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 17856-0538-6 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 17856-0538-7 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-0538-9 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-0538-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-0538-8 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-0538-5 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# NDC, Effective, Related label table NDC Effective Related label 17856-0538-1 2024-05-21 NYSTATIN ORAL SUSPENSION, USP 17856-0538-5 2024-05-21 NYSTATIN ORAL SUSPENSION, USP 17856-0538-6 2024-05-21 NYSTATIN ORAL SUSPENSION, USP 17856-0538-7 2024-05-21 NYSTATIN ORAL SUSPENSION, USP 17856-0538-8 2024-05-21 NYSTATIN ORAL SUSPENSION, USP 17856-0538-9 2024-05-21 NYSTATIN ORAL SUSPENSION, USP 17856-0538-1 2020-01-31 NYSTATIN ORAL SUSPENSION, USP 17856-0538-5 2020-01-31 NYSTATIN ORAL SUSPENSION, USP 17856-0538-6 2020-01-31 NYSTATIN ORAL SUSPENSION, USP 17856-0538-7 2020-01-31 NYSTATIN ORAL SUSPENSION, USP 17856-0538-8 2020-01-31 NYSTATIN ORAL SUSPENSION, USP 17856-0538-9 2020-01-31 NYSTATIN ORAL SUSPENSION, USP
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0538 NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.] 4 Legacy NDC 20240522_8d3531b9-13b4-471b-8315-9d05c80208f6.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.