nystatin

Product NDC: 68071-3508
Requested package NDC: 68071-3508-9
11-digit product format: 680713508
Labeler code: 68071
Product ID: 68071-3508_5968f53d-ca46-0c6e-e063-6394a90af3b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nystatin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA062474
Marketing category: ANDA
Marketing start: 2011-10-31
Substance: NYSTATIN
Active strength: 500000 [USP'U]/1
Pharmacologic classes: Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 9 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A062474-001	NYSTATIN	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA		1983-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062474-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062474-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	1983-12-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A062474-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062474-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062474-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062474-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062474-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062474-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062474-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062474-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062474-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062474-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062474-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062474-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062474-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062474-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062474-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062474-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062474-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062474-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062474-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062474-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062474-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062474-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062474-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062474-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062474-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062474-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062474-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062474-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062474-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062474-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062474-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062474-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062474-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062474-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062474-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062474-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062474-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062474-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062474-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062474-001	AA	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: nystatin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NYSTATIN	500000 [USP'U]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BDF1O1C72E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312059	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
05cc72dd-8e05-bfb5-e063-6394a90a92f1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
68071-3508-9	2025-01-30	C162847	48780-1	2cef2736-84ab-d83d-e063-dadaa90ab31f	Nystatin Tablets, USP (Oral) Rx only
68071-3508-9	2025-01-30	C162847	48780-1	2cef2736-84ab-d83d-e063-dadaa90ab31f	Nystatin Tablets, USP (Oral) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3508-9	nystatin	90 in 1 BOTTLE	TABLET, COATED	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3508	NYSTATIN TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]	1	Current NDC, 1 package rows	20230921_05cc72dd-8e05-bfb5-e063-6394a90a92f1.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	NuCare Pharmaceuticals,Inc.	05cc72dd-8e05-bfb5-e063-6394a90a92f1	2026-08-19	Adverse reactions	Exact identifier application applno (ANDA): 062474 application number: ANDA062474 ndc (package): 68071-3508-9 ndc (product): 68071-3508 ndc11 (package): 68071350809
nystatin	NYSTATIN	Preferred Pharmaceuticals Inc.	197e3046-3e58-4246-b260-f3995dce41a1	2026-08-05	Adverse reactions	Exact identifier application applno (ANDA): 062474 application number: ANDA062474
Nystatin	NYSTATIN	Chartwell RX, LLC	30175930-f5fa-403d-a3ac-3bdbbe723641	2025-12-17	Adverse reactions	Exact identifier application applno (ANDA): 062474 application number: ANDA062474
nystatin	NYSTATIN	Bryant Ranch Prepack	a5711dbe-f71c-435c-91f2-38c357532d18	2025-08-19	Adverse reactions	Exact identifier application applno (ANDA): 062474 application number: ANDA062474
nystatin	NYSTATIN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	e87b8480-987d-4f82-87bf-cf831d6984a1	2025-06-23	Adverse reactions	Exact identifier application applno (ANDA): 062474 application number: ANDA062474
nystatin	NYSTATIN	Proficient Rx LP	04d795f3-aad7-4b79-8ebc-43c500afe39b	2021-08-01	Adverse reactions	Exact identifier application applno (ANDA): 062474 application number: ANDA062474

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
312059	nystatin 500,000 UNT Oral Tablet	PSN	05cc72dd-8e05-bfb5-e063-6394a90a92f1	1
312059	nystatin 500000 UNT Oral Tablet	SCD	05cc72dd-8e05-bfb5-e063-6394a90a92f1	1
312059	nystatin 500,000 UNT Oral Tablet	SY	05cc72dd-8e05-bfb5-e063-6394a90a92f1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3508-9	68071350809	90 TABLET, COATED in 1 BOTTLE (68071-3508-9)	2023-09-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Tablets, USP (Oral) Rx only	NuCare Pharmaceuticals,Inc.	2026-08-19	HUMAN PRESCRIPTION DRUG LABEL	2