nystatin
- Product NDC
- 23155-051
- 11-digit product format
- 231550051
- Labeler code
- 23155
- Product ID
- 23155-051_d5c4ffad-b502-4226-9ff2-8603aac88dba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nystatin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA062474
- Marketing category
- ANDA
- Marketing start
- 2011-10-31
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062474-001 | NYSTATIN | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A062474-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A062474-001 | NYSTATIN | 500,000 UNITS | TABLET / ORAL | AA | 1983-12-22 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A062474-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A062474-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062474-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A062474-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062474-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062474-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062474-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062474-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062474-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062474-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062474-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062474-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062474-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062474-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062474-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062474-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062474-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062474-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062474-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062474-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062474-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062474-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062474-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A062474-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062474-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062474-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062474-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062474-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062474-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A062474-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A062474-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062474-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062474-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062474-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062474-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A062474-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A062474-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062474-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A062474-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A062474-001 | AA | 1 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- nystatin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NYSTATIN | 500000 [USP'U]/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| BDF1O1C72E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312059 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e87b8480-987d-4f82-87bf-cf831d6984a1 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e29fe634-dc25-094c-c77f-5d09c3eceb3e | Product name | 5 | 20260107 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| e57b6340-9387-3f9a-7307-511c81791375 | Product name | 3 | 20221214 |
| 544f8e8d-6389-eeeb-9586-aa447c08dcc7 | Product name | 5 | 20210614 |
| 1629e00f-54fb-4a43-8306-b58442b23902 | Product name | 9 | 20200430 |
| 854ec07b-1cd7-a5db-235a-7aa24d3cf97a | Product name | 3 | 20180628 |
| 19b9f4c1-15e9-edcc-4c16-f01ecfb5c549 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 23155-051-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5335-111a-e063-dadaa90a10e2 | Nystatin Tablets, USP (Oral) Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 23155-051-01 | nystatin | 100 in 1 BOTTLE | TABLET, COATED | 100 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 23155-051-01 | EA - Each | 23155-051 | 4085917d-e82a-4fb5-9eb4-f46d87d65f7f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | NYSTATIN | NuCare Pharmaceuticals,Inc. | 05cc72dd-8e05-bfb5-e063-6394a90a92f1 | 2026-08-19 | Adverse reactions | 062474 ANDA062474 |
| nystatin | NYSTATIN | Preferred Pharmaceuticals Inc. | 197e3046-3e58-4246-b260-f3995dce41a1 | 2026-08-05 | Adverse reactions | 062474 ANDA062474 |
| Nystatin | NYSTATIN | Chartwell RX, LLC | 30175930-f5fa-403d-a3ac-3bdbbe723641 | 2025-12-17 | Adverse reactions | 062474 ANDA062474 |
| nystatin | NYSTATIN | Bryant Ranch Prepack | a5711dbe-f71c-435c-91f2-38c357532d18 | 2025-08-19 | Adverse reactions | 062474 ANDA062474 |
| nystatin | NYSTATIN | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | e87b8480-987d-4f82-87bf-cf831d6984a1 | 2025-06-23 | Adverse reactions | 062474 ANDA062474 23155-051 |
| nystatin | NYSTATIN | Proficient Rx LP | 04d795f3-aad7-4b79-8ebc-43c500afe39b | 2021-08-01 | Adverse reactions | 062474 ANDA062474 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 23155-051-01 | 23155005101 | 100 TABLET, COATED in 1 BOTTLE (23155-051-01) | 2011-10-31 | 0000-00-00 | No | No | Current |