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
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 17856-0538 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 17856-0538 | 17856-0538-1 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 17856-0538 | 17856-0538-5 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 17856-0538 | 17856-0538-6 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 17856-0538 | 17856-0538-7 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 17856-0538 | 17856-0538-8 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 17856-0538 | 17856-0538-9 | D | Discontinued by firm | 2026-10-05 |
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.
| 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… |
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A062512-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1984-10-29 | 84e616aacf4f… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A062512-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A062512-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A062512-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062512-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A062512-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062512-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062512-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062512-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062512-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062512-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062512-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062512-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062512-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062512-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062512-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062512-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062512-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062512-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062512-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062512-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062512-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062512-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062512-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062512-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A062512-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062512-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062512-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062512-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062512-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062512-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A062512-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A062512-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062512-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062512-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062512-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062512-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A062512-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A062512-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062512-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A062512-001 | AA | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nystatin Oral Suspension | NYSTATIN | Xttrium Laboratories, Inc. | 4a670371-d373-1ba6-e063-6394a90a13b6 | 2026-02-06 | Adverse reactions | 062512 ANDA062512 |
| Nystatin | NYSTATIN | A-S Medication Solutions | e069d495-7f1a-4970-8f4d-aa93d124b3fc | 2023-02-04 | Adverse reactions | 062512 ANDA062512 |