Nystatin

Product NDC: 68071-2887
11-digit product format: 680712887
Labeler code: 68071
Product ID: 68071-2887_ee16e538-95bc-e59f-e053-2a95a90afc10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA212557
Marketing category: ANDA
Marketing start: 2019-07-24
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 U/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2887		I	Inactivated by FDA		2026-08-17
excluded package	package	68071-2887	68071-2887-3	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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2887-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2887-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2887-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2887-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2887-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2887-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2887-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2887-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2887-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A212557-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT		2019-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212557-001	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 · 41 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	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A212557-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212557-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212557-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212557-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212557-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212557-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212557-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212557-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212557-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212557-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212557-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212557-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212557-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212557-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212557-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212557-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212557-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212557-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212557-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212557-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212557-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212557-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212557-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212557-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212557-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212557-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212557-001	AT	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212557-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212557-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212557-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212557-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212557-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212557-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212557-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212557-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212557-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212557-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212557-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212557-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212557-001	AT	1	`cb3db0bc1861…`

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
68071-2887-3	2025-01-30	C162847	48780-1	2cef2736-7e1f-d83d-e063-dadaa90ab31f	Nystatin Cream USP, 100,000 units per gram FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2887-3	Nystatin	30 g in 1 TUBE	CREAM	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2887	NYSTATIN CREAM [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20221124_ee16e52c-ebb0-3330-e053-2995a90af2e8.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	Preferred Pharmaceuticals Inc.	d92f67a7-dcae-41c0-9a35-dbafa2361170	2026-08-04	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	Bryant Ranch Prepack	2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc	2026-07-09	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	Torrent Pharmaceuticals Limited	559b5bd4-3564-4437-8d0a-fa3a972f8b83	2026-05-01	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	RedPharm Drug, Inc	f4c298d5-b012-7b56-e053-2a95a90a3d55	2026-01-24	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	A-S Medication Solutions	65167baa-29f8-44d3-b2d2-935c862d463e	2024-10-16	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	Proficient Rx LP	8566c432-741f-4af7-91d7-1b7668ce5e95	2023-12-01	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557

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
543546	nystatin 100,000 UNT/GM Topical Cream	PSN	ee16e52c-ebb0-3330-e053-2995a90af2e8	1
543546	nystatin 100000 UNT/ML Topical Cream	SCD	ee16e52c-ebb0-3330-e053-2995a90af2e8	1
543546	nystatin 100,000 UNT/GM Topical Cream	SY	ee16e52c-ebb0-3330-e053-2995a90af2e8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2887-3	68071288703	30 g in 1 TUBE (68071-2887-3)	30 g	2022-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Cream USP, 100,000 units per gram FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE	NuCare Pharmaceuticals,Inc.	2022-11-22	HUMAN PRESCRIPTION DRUG LABEL	1