Nystatin

Product NDC: 68071-2483
11-digit product format: 680712483
Labeler code: 68071
Product ID: 68071-2483_c80acf66-e967-414e-e053-2a95a90a8f3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA061966
Marketing category: ANDA
Marketing start: 2015-04-01
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 [USP'U]/g
Pharmacologic classes: Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	68071-2483		D	Discontinued by firm		2026-08-17
excluded package	package	68071-2483	68071-2483-3	D	Discontinued by firm		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 · 30 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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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	68071-2483-3	`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
A061966-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A061966-001	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	Source SHA-256
2026-08-18 06:07:40	2026-07	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A061966-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`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	A061966-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061966-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061966-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061966-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061966-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061966-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061966-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061966-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061966-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061966-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061966-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061966-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061966-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061966-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061966-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061966-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061966-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061966-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061966-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061966-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061966-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061966-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A061966-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A061966-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061966-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061966-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061966-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061966-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061966-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061966-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061966-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061966-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061966-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061966-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061966-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A061966-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A061966-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061966-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A061966-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A061966-001	AT	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2483-3	2023-01-30	C162847	48780-1	f386c64a-121f-0266-e053-dadaa90a7c1a	c80acf66-e966-414e-e053-2a95a90a8f3a

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2483	NYSTATIN (NYSTATIN CREAM) CREAM [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC	20210727_c80acf66-e966-414e-e053-2a95a90a8f3a.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	A-S Medication Solutions	98bd8ccb-0c68-47b9-bcb4-c5d8217868d9	2026-07-24	Adverse reactions	Exact identifier application applno (ANDA): 061966 application number: ANDA061966
Nystatin	NYSTATIN CREAM	NuCare Pharmaceuticals, Inc.	42f21220-c68a-d748-e063-6394a90a1e2f	2025-11-06	Adverse reactions	Exact identifier application applno (ANDA): 061966 application number: ANDA061966
Nystatin	NYSTATIN	A-S Medication Solutions	a1b5ccb2-d0d6-46cc-b792-6920b50d0a03	2025-05-15	Adverse reactions	Exact identifier application applno (ANDA): 061966 application number: ANDA061966
Nystatin	NYSTATIN CREAM	Cosette Pharmaceuticals, Inc.	ec1b52af-d38e-eba1-e63c-dba4341d3af2	2022-11-22	Adverse reactions	Exact identifier application applno (ANDA): 061966 application number: ANDA061966
Nystatin	NYSTATIN CREAM	Proficient Rx LP	b1efcc2c-f71a-463d-9a02-fad7550f31ec	2022-11-01	Adverse reactions	Exact identifier application applno (ANDA): 061966 application number: ANDA061966

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	Marketing end	Sample	Exclude flag	Status
68071-2483-3	68071248303	1 TUBE in 1 CARTON (68071-2483-3) > 30 g in 1 TUBE	1 tube	2021-07-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Cream - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-07-26	HUMAN PRESCRIPTION DRUG LABEL	1