Nystatin

Product NDC: 42254-303
11-digit product format: 422540303
Labeler code: 42254
Product ID: 42254-303_1211504c-f89b-42ed-9d7a-2e1a658a9ccf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: POWDER
Route: TOPICAL
Labeler: Rebel Distributors Corp
Application: ANDA065203
Marketing category: ANDA
Marketing start: 2009-09-15
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 [USP'U]/g
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	42254-303		I	Inactivated by FDA		2026-07-31
excluded package	package	42254-303	42254-303-15	I	Inactivated by FDA		2026-07-31

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
A065203-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065203-001	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.

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
2026-08-01 22:54:32	2026-06	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A065203-001	AT	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Dr. Reddy's Labratories Inc.	6bde84a1-341d-09ce-58b6-f9a653dc98c5	2024-04-12	Adverse reactions	Exact identifier application applno (ANDA): 065203 application number: ANDA065203

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
42254-303-15	2019-09-24	C162847	48780-1	9350213a-3d8e-c013-e053-90daa90a1393	NYSTATIN TOPICAL POWDER, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-303-15	Nystatin	15 g in 1 BOTTLE, PLASTIC	POWDER	15		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-303-15	GM - Gram	42254-303	f2707c38-30ad-4bb7-bcce-0b8212fc0ce4	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Nystatin	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN POWDER [REBEL DISTRIBUTORS CORP]	1
Nystatin	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN POWDER [REBEL DISTRIBUTORS CORP]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	NYSTATIN POWDER [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-303	NYSTATIN POWDER [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20130329_1211504c-f89b-42ed-9d7a-2e1a658a9ccf.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
646456	nystatin 100,000 UNT/GM Topical Powder	PSN	1211504c-f89b-42ed-9d7a-2e1a658a9ccf	1
646456	nystatin 100 UNT/MG Topical Powder	SCD	1211504c-f89b-42ed-9d7a-2e1a658a9ccf	1
646456	nystatin 100,000 UNT/GM Topical Powder	SY	1211504c-f89b-42ed-9d7a-2e1a658a9ccf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42254-303-15	42254030315	15 g in 1 BOTTLE, PLASTIC	15 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NYSTATIN TOPICAL POWDER, USP	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-09-26	HUMAN PRESCRIPTION DRUG LABEL	1