Nystatin

Product NDC: 66689-008
Requested package NDC: 66689-008-02
11-digit product format: 666890008
Labeler code: 66689
Product ID: 66689-008_beaf5815-9659-4ba3-ac23-6e734f4afc05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: SUSPENSION
Route: ORAL
Labeler: VistaPharm, Inc.
Application: ANDA064142
Marketing category: ANDA
Marketing start: 2012-05-01
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 [USP'U]/mL
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	66689-008	66689-008-02	D	Discontinued by firm		2026-08-11

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A064142-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL			1998-06-25
A064142-002	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL			2011-03-07

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 · 70 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
2026-02-19 14:30 UTC	2026-02	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1998-06-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		2011-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064142-002	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064142-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1998-06-25	`3f01610625f2…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064142-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064142-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064142-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064142-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064142-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064142-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064142-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064142-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064142-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064142-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064142-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064142-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064142-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064142-001	AA	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064142-001	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064142-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064142-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064142-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064142-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064142-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064142-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A064142-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064142-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A064142-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064142-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064142-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064142-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A064142-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064142-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A064142-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064142-001	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064142-002	AA	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
66689-008-02	2024-01-30	C162847	48780-1	1030e365-1c06-111a-e063-dadaa90a10e2	NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL
66689-008-08	2024-01-30	C162847	48780-1	1030e365-1c06-111a-e063-dadaa90a10e2	NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL
66689-008-16	2024-01-30	C162847	48780-1	1030e365-1c06-111a-e063-dadaa90a10e2	NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-008-02	ML - Milliliter	66689-008	e63a7936-f9a8-4bfe-bce4-ea8756f5be60	1	2013-03-03
66689-008-16	ML - Milliliter	66689-008	96d8d758-76b3-4bd8-bb50-b0ffa58d8df4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Nystatin	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Nystatin	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Alcohol	INACTIVE INGREDIENT	3K9958V90M	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Saccharin Sodium Dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Sodium Phosphate, Monobasic, Monohydrate	INACTIVE INGREDIENT	593YOG76RN	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Sucrose	INACTIVE INGREDIENT	C151H8M554	NYSTATIN SUSPENSION [VISTAPHARM, INC]	3
Nystatin	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Nystatin	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Alcohol	INACTIVE INGREDIENT	3K9958V90M	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Saccharin Sodium Dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Sodium Phosphate, Dibasic	INACTIVE INGREDIENT	GR686LBA74	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Sodium Phosphate, Monobasic	INACTIVE INGREDIENT	3980JIH2SW	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Sucrose	INACTIVE INGREDIENT	C151H8M554	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN SUSPENSION [VISTAPHARM INC.]	2

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
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	5a07151e-0a9f-4ca5-b7b2-d954e8c33a27	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	5a07151e-0a9f-4ca5-b7b2-d954e8c33a27	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	5a07151e-0a9f-4ca5-b7b2-d954e8c33a27	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	5a07151e-0a9f-4ca5-b7b2-d954e8c33a27	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66689-008-02	66689000802	60 mL in 1 BOTTLE (66689-008-02)	60 ml	2012-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	103
NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	103
NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL	VistaPharm, LLC	2024-07-30	HUMAN PRESCRIPTION DRUG LABEL	8
NYSTATIN ORAL SUSPENSION, USP	ATLANTIC BIOLOGICALS CORP.	2023-01-19	HUMAN PRESCRIPTION DRUG LABEL	1
NYSTATIN ORAL SUSPENSION, USP	VistaPharm, Inc.	2019-09-19	HUMAN PRESCRIPTION DRUG LABEL	11