Nystatin

Product NDC: 68788-4099
11-digit product format: 687884099
Labeler code: 68788
Product ID: 68788-4099_a97b4fa6-c1a7-4003-9321-3717eb640ea9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA213566
Marketing category: ANDA
Marketing start: 2026-07-06
Substance: NYSTATIN
Active strength: 100000 [USP'U]/g
Pharmacologic classes: Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213566-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT		2021-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A213566-001	AT

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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213566-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2021-08-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213566-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213566-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213566-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213566-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213566-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213566-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213566-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213566-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213566-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213566-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213566-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213566-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213566-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213566-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213566-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213566-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213566-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213566-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213566-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213566-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213566-001	AT	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213566-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213566-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213566-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213566-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213566-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213566-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213566-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213566-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213566-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213566-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213566-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213566-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213566-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213566-001	AT	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Nystatin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NYSTATIN	100000 [USP'U]/g

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
543546	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a97b4fa6-c1a7-4003-9321-3717eb640ea9	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Preferred Pharmaceuticals Inc.	a97b4fa6-c1a7-4003-9321-3717eb640ea9	2026-07-06	Adverse reactions	Exact identifier application applno (ANDA): 213566 application number: ANDA213566 ndc (product): 68788-4099
Nystatin	NYSTATIN	Bryant Ranch Prepack	b6aa24e6-1acb-4fd3-9ec7-11b1a69c1598	2025-10-08	Adverse reactions	Exact identifier application applno (ANDA): 213566 application number: ANDA213566
Nystatin	NYSTATIN	Macleods Pharmaceuticals Limited	d8ebb61a-a326-4f0d-a346-c3db045c3fb0	2021-08-25	Adverse reactions	Exact identifier application applno (ANDA): 213566 application number: ANDA213566

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BDF1O1C72E	NYSTATIN	1400-61-9	NYSTATIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4099-1	68788409901	1 TUBE in 1 CARTON (68788-4099-1) / 15 g in 1 TUBE	1 tube	2026-07-06	No	No	Current