Nystatin

Product NDC: 21695-643
11-digit product format: 216950643
Labeler code: 21695
Product ID: 21695-643_29ccf947-91c1-405a-aba6-5889e3c75d70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA065148
Marketing category: ANDA
Marketing start: 2005-06-28
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 [USP'U]/mL
Pharmacologic classes: Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-643		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-643	21695-643-60	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 · 44 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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`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	21695-643-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-643-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-643-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-643-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-643-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-643-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-643-60	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-643-60	`110d247fa046…`	`a55b01930146…`

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
A065148-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		2005-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065148-001	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	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065148-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2005-06-28	`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	A065148-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065148-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065148-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065148-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065148-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065148-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065148-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065148-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065148-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065148-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065148-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065148-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065148-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065148-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065148-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065148-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065148-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065148-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065148-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065148-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065148-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065148-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065148-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065148-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065148-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065148-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065148-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065148-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065148-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065148-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065148-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065148-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065148-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065148-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065148-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065148-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065148-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065148-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065148-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065148-001	AA	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
e57b6340-9387-3f9a-7307-511c81791375	Product name	3	20221214
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
544f8e8d-6389-eeeb-9586-aa447c08dcc7	Product name	5	20210614
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
854ec07b-1cd7-a5db-235a-7aa24d3cf97a	Product name	3	20180628
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-643-60	2019-09-24	C162847	48780-1	934fe258-4845-48b1-e053-8cdaa90a720a	NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-643-60	Nystatin	60 mL in 1 BOTTLE, DROPPER	SUSPENSION	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-643-60	ML - Milliliter	21695-643	20738cb3-086c-472e-b196-a47c69fed8bf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NYSTATIN	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
NYSTATIN	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-643	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110113_29ccf947-91c1-405a-aba6-5889e3c75d70.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NYSTATIN	NYSTATIN	Genus Lifesciences Inc.	b25cbae5-eaf5-4501-b013-02c778ca4a4e	2026-05-07	Adverse reactions	Exact identifier application applno (ANDA): 065148 application number: ANDA065148

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	29ccf947-91c1-405a-aba6-5889e3c75d70	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	29ccf947-91c1-405a-aba6-5889e3c75d70	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	29ccf947-91c1-405a-aba6-5889e3c75d70	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	29ccf947-91c1-405a-aba6-5889e3c75d70	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-643-60	21695064360	60 mL in 1 BOTTLE, DROPPER	60 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL	Rebel Distributors Corp	2011-01-03	HUMAN PRESCRIPTION DRUG LABEL	1