Nystatin

Product NDC: 42254-322
11-digit product format: 422540322
Labeler code: 42254
Product ID: 42254-322_8ce02e76-303c-4e06-a47e-0a7bbf46c3f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA064042
Marketing category: ANDA
Marketing start: 2012-01-27
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 [USP'U]/mL
Pharmacologic classes: Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	42254-322		I	Inactivated by FDA		2026-08-17
excluded package	package	42254-322	42254-322-60	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 · 44 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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`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	42254-322-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-322-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-322-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-322-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-322-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-322-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-322-60	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-322-60	`110d247fa046…`	`a55b01930146…`

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
A064042-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL			1994-02-28

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`e64feba35796…`

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	A064042-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064042-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064042-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064042-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064042-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064042-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064042-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064042-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064042-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064042-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064042-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064042-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064042-001	AA	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A064042-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064042-001	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
42254-322-60	2019-09-24	C162847	48780-1	9350213a-3cc2-c013-e053-90daa90a1393	Nystatin Oral Suspension, USP 100,000 units per mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-322-60	Nystatin	60 mL in 1 BOTTLE, DROPPER	SUSPENSION	60		1
42254-322-60	Nystatin	1 in 1 CARTON	SUSPENSION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-322-60	ML - Milliliter	42254-322	552f0046-9251-42f2-85df-72ca31d92f84	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NYSTATIN	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
NYSTATIN	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-322	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20130329_8ce02e76-303c-4e06-a47e-0a7bbf46c3f2.zip

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	8ce02e76-303c-4e06-a47e-0a7bbf46c3f2	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	8ce02e76-303c-4e06-a47e-0a7bbf46c3f2	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	8ce02e76-303c-4e06-a47e-0a7bbf46c3f2	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	8ce02e76-303c-4e06-a47e-0a7bbf46c3f2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42254-322-60	42254032260	60 mL in 1 BOTTLE, DROPPER	60 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Oral Suspension, USP 100,000 units per mL	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-10-16	HUMAN PRESCRIPTION DRUG LABEL	1