NYSTATIN

Product NDC: 75834-235
11-digit product format: 758340235
Labeler code: 75834
Product ID: 75834-235_f3a36e96-d16e-4c87-903d-b7f797d9c204
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NYSTATIN
Dosage form: SUSPENSION
Route: ORAL
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA062832
Marketing category: ANDA
Marketing start: 2020-08-14
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: 2023-12-31
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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75834-235		I	Inactivated by FDA	2026-08-17
excluded package	package	75834-235	75834-235-16	I	Inactivated by FDA	2026-08-17
excluded package	package	75834-235	75834-235-60	I	Inactivated by FDA	2026-08-17

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 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75834-235-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75834-235-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75834-235-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75834-235-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75834-235-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75834-235-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75834-235-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75834-235-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75834-235-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75834-235-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75834-235-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75834-235-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75834-235-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75834-235-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75834-235-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75834-235-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75834-235-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75834-235-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75834-235-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75834-235-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75834-235-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75834-235-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75834-235-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75834-235-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75834-235-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75834-235-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75834-235-16	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75834-235-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75834-235-16	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75834-235-60	`1332a3947898…`	`d4bfe170f9cd…`

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
A062832-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1991-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062832-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A062832-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062832-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062832-001	AA	1	`31067a03dcf5…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062832-001	AA	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062832-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062832-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062832-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062832-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062832-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062832-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062832-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A062832-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062832-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062832-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062832-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062832-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062832-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062832-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062832-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062832-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062832-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062832-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062832-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062832-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062832-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062832-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062832-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062832-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062832-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062832-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062832-001	AA	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
75834-235-16	2024-01-30	NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
75834-235-60	2024-01-30	NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
75834-235-16	2022-02-16	NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
75834-235-60	2022-02-16	NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
75834-235-16	2022-01-28	NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
75834-235-60	2022-01-28	NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75834-235-16	NYSTATIN	473 mL in 1 BOTTLE	SUSPENSION	473	2
75834-235-60	NYSTATIN	1 in 1 CARTON	SUSPENSION	1	2
75834-235-60	NYSTATIN	60 mL in 1 BOTTLE, DROPPER	SUSPENSION	60	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-235	NYSTATIN SUSPENSION [NIVAGEN PHARMACEUTICALS, INC.]	2	Legacy NDC, 3 package rows	20220217_dddbaf12-ecb1-4bd2-8a15-2f75578a8d8d.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NYSTATIN	NYSTATIN	Kesin Pharma Corporation	50737729-a4a4-e747-e063-6394a90adcc5	2026-06-30	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Bryant Ranch Prepack	4f6f59fb-ae7d-48e5-b23e-a1d92160974f	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Kesin Pharma Corporation	43817169-bbe8-58ee-e063-6294a90a1250	2025-12-11	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Kanchan Healthcare Inc	90a52c3f-3ef7-4f3b-9fe5-40af408e9f2a	2025-09-12	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Bryant Ranch Prepack	b06c65cd-5b65-4bc6-aae9-b9381c6f1948	2023-01-26	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832

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
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	b06c65cd-5b65-4bc6-aae9-b9381c6f1948	103
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	b06c65cd-5b65-4bc6-aae9-b9381c6f1948	103
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	b06c65cd-5b65-4bc6-aae9-b9381c6f1948	103
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	b06c65cd-5b65-4bc6-aae9-b9381c6f1948	103
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	dddbaf12-ecb1-4bd2-8a15-2f75578a8d8d	2
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	dddbaf12-ecb1-4bd2-8a15-2f75578a8d8d	2
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	dddbaf12-ecb1-4bd2-8a15-2f75578a8d8d	2
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	dddbaf12-ecb1-4bd2-8a15-2f75578a8d8d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-235-16	75834023516	473 mL in 1 BOTTLE (75834-235-16)	473 ml	2020-08-14	0000-00-00	No	No	Current
75834-235-60	75834023560	1 BOTTLE, DROPPER in 1 CARTON (75834-235-60) > 60 mL in 1 BOTTLE, DROPPER		2020-08-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	104
NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	104
NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)	Bryant Ranch Prepack	2023-01-26	HUMAN PRESCRIPTION DRUG LABEL	103
NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)	Nivagen Pharmaceuticals, Inc.	2022-02-16	HUMAN PRESCRIPTION DRUG LABEL	2