Nystatin

Product NDC: 21695-761
11-digit product format: 216950761
Labeler code: 21695
Product ID: 21695-761_fb98a6b8-da0c-40f4-9e53-487b541865b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: CREAM
Route: TOPICAL
Labeler: Rebel Distributors Corp
Application: ANDA064022
Marketing category: ANDA
Marketing start: 1993-01-29
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 mg/g
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-761		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-761	21695-761-15	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-761	21695-761-30	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 2 · 66 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	21695-761-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-761-15	`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	21695-761-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-761-15	`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	21695-761-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-761-15	`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	21695-761-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-761-15	`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	21695-761-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-761-15	`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	21695-761-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-761-15	`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	21695-761-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-761-15	`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	21695-761-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-761-15	`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	21695-761-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-761-15	`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	21695-761-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-761-15	`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	21695-761-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-761-15	`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	21695-761-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-761-15	`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	21695-761-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-761-15	`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	21695-761-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-761-15	`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	21695-761-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-761-15	`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	21695-761-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-761-15	`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	21695-761-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-761-15	`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	21695-761-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-761-15	`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	21695-761-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-761-15	`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	21695-761-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-761-15	`e2bbac7714bc…`	`27bdfed8d636…`

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
A064022-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064022-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`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	A064022-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064022-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064022-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064022-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064022-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064022-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064022-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064022-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064022-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064022-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064022-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064022-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064022-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064022-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064022-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064022-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064022-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064022-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064022-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064022-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064022-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064022-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064022-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064022-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064022-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064022-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064022-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064022-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064022-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064022-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064022-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064022-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064022-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064022-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064022-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064022-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064022-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064022-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064022-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064022-001	AT	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-761-15	2019-09-24	C162847	48780-1	934fe258-487e-48b1-e053-8cdaa90a720a	Nystatin Cream USP, 100,000 units per gram
21695-761-30	2019-09-24	C162847	48780-1	934fe258-487e-48b1-e053-8cdaa90a720a	Nystatin Cream USP, 100,000 units per gram

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-761-15	Nystatin	15 g in 1 TUBE	CREAM	15	1
21695-761-15	Nystatin	1 in 1 CARTON	CREAM	1	1
21695-761-30	Nystatin	1 in 1 CARTON	CREAM	1	1
21695-761-30	Nystatin	30 g in 1 TUBE	CREAM	30	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-761-15	GM - Gram	21695-761	b5aaac98-43a4-4919-9a1e-74408bbaa008	1	2012-07-24
21695-761-30	GM - Gram	21695-761	3246afc3-3809-4ac8-b4ed-6770e5e0b180	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Nystatin	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
Nystatin	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
ALGELDRATE	INACTIVE INGREDIENT	03J11K103C	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
CETEARETH-12	INACTIVE INGREDIENT	7V4MR24V5P	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-761	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 4 package rows	20101124_fb98a6b8-da0c-40f4-9e53-487b541865b5.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	Sun Pharmaceutical Industries, Inc.	4d845b3f-ca26-4c47-b424-b6d783cc10e5	2025-07-03	Adverse reactions	Exact identifier application applno (ANDA): 064022 application number: ANDA064022
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	cf6b7c68-7769-1808-e053-2995a90aa426	2025-02-10	Adverse reactions	Exact identifier application applno (ANDA): 064022 application number: ANDA064022
NYSTATIN	NYSTATIN	DIRECT RX	cd387929-5b72-e3c0-e053-2a95a90adb22	2025-01-20	Adverse reactions	Exact identifier application applno (ANDA): 064022 application number: ANDA064022
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	57825c04-dcb5-b76d-e053-2991aa0a4c1d	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 064022 application number: ANDA064022
Nystatin	NYSTATIN	Proficient Rx LP	5ef15e1c-66dc-4858-8552-d83e42c3883e	2019-11-01	Adverse reactions	Exact identifier application applno (ANDA): 064022 application number: ANDA064022

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	Status
21695-761-15	21695076115	15 g in 1 TUBE	15 g	Historical
21695-761-30	21695076130	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Cream USP, 100,000 units per gram	Rebel Distributors Corp	2010-10-08	HUMAN PRESCRIPTION DRUG LABEL	1