Nystatin

Product NDC: 72578-089
11-digit product format: 725780089
Labeler code: 72578
Product ID: 72578-089_3d917a6c-4e9a-4c45-9e79-caf91f8b11b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Viona Pharmaceuticals Inc
Application: ANDA207767
Marketing category: ANDA
Marketing start: 2020-06-24
Substance: NYSTATIN
Active strength: 100000 U/g
Pharmacologic classes: Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A207767-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT		2018-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207767-001	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.

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207767-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207767-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207767-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207767-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207767-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207767-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207767-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207767-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207767-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207767-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207767-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207767-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207767-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207767-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207767-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207767-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207767-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207767-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207767-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207767-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207767-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207767-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207767-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207767-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207767-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207767-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207767-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207767-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207767-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207767-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207767-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207767-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207767-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207767-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207767-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207767-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207767-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207767-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207767-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207767-001	AT	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nystatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NYSTATIN	100000 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
884308	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
e135a7d2-adba-48a2-b3e1-07b778cce9b0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72578-089-01	Nystatin	15 g in 1 TUBE	OINTMENT	15		4
72578-089-04	Nystatin	30 g in 1 TUBE	OINTMENT	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72578-089	NYSTATIN OINTMENT [VIONA PHARMACEUTICALS INC]	4	Current NDC, Legacy NDC, 2 package rows	20221122_e135a7d2-adba-48a2-b3e1-07b778cce9b0.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Zydus Lifesciences Limited	6aa2f67e-9636-45e5-be1b-83e7ab86e436	2024-08-16		Exact identifier application applno (ANDA): 207767 application number: ANDA207767
Nystatin	NYSTATIN	Bryant Ranch Prepack	93d59122-86f3-489d-9790-1ef6c6aff89d	2024-03-26	Adverse reactions	Exact identifier application applno (ANDA): 207767 application number: ANDA207767
Nystatin	NYSTATIN	A-S Medication Solutions	6a3bb3da-adf9-46d2-a5ff-f796e7aae7a1	2023-11-24	Adverse reactions	Exact identifier application applno (ANDA): 207767 application number: ANDA207767
Nystatin	NYSTATIN	Bryant Ranch Prepack	53d1c23b-9cf2-4941-8701-8a7da1b066cc	2023-03-03	Adverse reactions	Exact identifier application applno (ANDA): 207767 application number: ANDA207767
Nystatin	NYSTATIN	Bryant Ranch Prepack	84383bc5-1282-43d6-9303-23c8fd8d075f	2023-03-03	Adverse reactions	Exact identifier application applno (ANDA): 207767 application number: ANDA207767
Nystatin	NYSTATIN	Viona Pharmaceuticals Inc	e135a7d2-adba-48a2-b3e1-07b778cce9b0	2022-10-08	Adverse reactions	Exact identifier application applno (ANDA): 207767 application number: ANDA207767 ndc (product): 72578-089

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884308	nystatin 100,000 UNT/GM Topical Ointment	PSN	53d1c23b-9cf2-4941-8701-8a7da1b066cc	102
884308	nystatin 100,000 UNT/GM Topical Ointment	PSN	84383bc5-1282-43d6-9303-23c8fd8d075f	102
884308	nystatin 100 UNT/MG Topical Ointment	SCD	53d1c23b-9cf2-4941-8701-8a7da1b066cc	102
884308	nystatin 100 UNT/MG Topical Ointment	SCD	84383bc5-1282-43d6-9303-23c8fd8d075f	102
884308	nystatin 100,000 UNT/GM Topical Ointment	SY	53d1c23b-9cf2-4941-8701-8a7da1b066cc	102
884308	nystatin 100,000 UNT/GM Topical Ointment	SY	84383bc5-1282-43d6-9303-23c8fd8d075f	102
884308	nystatin 100,000 UNT/GM Topical Ointment	PSN	93d59122-86f3-489d-9790-1ef6c6aff89d	101
884308	nystatin 100 UNT/MG Topical Ointment	SCD	93d59122-86f3-489d-9790-1ef6c6aff89d	101
884308	nystatin 100,000 UNT/GM Topical Ointment	SY	93d59122-86f3-489d-9790-1ef6c6aff89d	101
884308	nystatin 100,000 UNT/GM Topical Ointment	PSN	6a3bb3da-adf9-46d2-a5ff-f796e7aae7a1	5
884308	nystatin 100 UNT/MG Topical Ointment	SCD	6a3bb3da-adf9-46d2-a5ff-f796e7aae7a1	5
884308	nystatin 100,000 UNT/GM Topical Ointment	SY	6a3bb3da-adf9-46d2-a5ff-f796e7aae7a1	5
884308	nystatin 100,000 UNT/GM Topical Ointment	PSN	e135a7d2-adba-48a2-b3e1-07b778cce9b0	4
884308	nystatin 100 UNT/MG Topical Ointment	SCD	e135a7d2-adba-48a2-b3e1-07b778cce9b0	4
884308	nystatin 100,000 UNT/GM Topical Ointment	SY	e135a7d2-adba-48a2-b3e1-07b778cce9b0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72578-089-01	72578008901	15 g in 1 TUBE (72578-089-01)	15 g	2020-06-24	0000-00-00	No	No	Current
72578-089-04	72578008904	30 g in 1 TUBE (72578-089-04)	30 g	2020-06-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Ointment, USP	Bryant Ranch Prepack	2024-03-26	HUMAN PRESCRIPTION DRUG LABEL	101
Nystatin Ointment, USP	A-S Medication Solutions	2023-11-24	HUMAN PRESCRIPTION DRUG LABEL	5
Nystatin Ointment, USP	Bryant Ranch Prepack	2023-03-03	HUMAN PRESCRIPTION DRUG LABEL	102
Nystatin Ointment, USP	Bryant Ranch Prepack	2023-03-03	HUMAN PRESCRIPTION DRUG LABEL	102
Nystatin Ointment, USP	Viona Pharmaceuticals Inc \| Zydus Lifesciences Limited	2022-10-08	HUMAN PRESCRIPTION DRUG LABEL	4