Nystatin

Product NDC: 68788-7949
Requested package NDC: 68788-7949-3
11-digit product format: 687887949
Labeler code: 68788
Product ID: 68788-7949_33f2203b-39c0-4416-a4f3-c2d5a583b911
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA064022
Marketing category: ANDA
Marketing start: 2021-07-08
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7949	68788-7949-3	D	Discontinued by firm		2026-08-03

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7949	68788-7949-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064022-001	AT	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7949-1	GM - Gram	68788-7949	490ff946-494d-4d1b-90f6-951414109d5b	1	2021-08-05
68788-7949-3	GM - Gram	68788-7949	7893ccb9-42aa-4c9e-9c33-eba32d80c334	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7949	NYSTATIN CREAM [PREFERRED PHARMACEUTICALS INC.]	4	Legacy NDC	20240725_072c41d8-190a-425a-8427-bdccaef7527b.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	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7949-3	68788794903	1 TUBE in 1 CARTON (68788-7949-3) > 30 g in 1 TUBE	1 tube	2021-07-08	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	Preferred Pharmaceuticals Inc. \| Preferred PharmaceuticalsInc.	2024-07-23	HUMAN PRESCRIPTION DRUG LABEL	4