Nystatin

Product NDC: 63187-847
11-digit product format: 631870847
Labeler code: 63187
Product ID: 63187-847_d13c0ace-65a3-4d56-bfce-c4aa234af26b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: CREAM
Route: TOPICAL
Labeler: Proficient Rx LP
Application: ANDA062225
Marketing category: ANDA
Marketing start: 2006-09-21
Substance: NYSTATIN
Active strength: 100000 [USP'U]/g
Pharmacologic classes: Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A062225-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062225-001	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	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982		`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	A062225-001	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycostatin	NYSTATIN	Direct_Rx	f1857ac0-806c-4a7e-e053-2995a90abbc0	2026-03-17	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	A-S Medication Solutions	f1b13a36-c349-4e26-a322-3ec02c610155	2026-03-16	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Bryant Ranch Prepack	b71356cf-7b6e-4ca0-9571-c80fd0d846cb	2025-10-23	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Bryant Ranch Prepack	840eebe8-5de2-40c5-acfd-03a98b2e790e	2025-09-23	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Bryant Ranch Prepack	cc8f9a06-cd1b-40e9-bc22-7e19f6d89b83	2025-04-02	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	6599b544-60bd-ab30-e053-2a91aa0a67b6	2024-11-20	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	A-S Medication Solutions	f410ba07-9183-40a8-a2a6-46d3e9761470	2024-11-06	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Bryant Ranch Prepack	b69d9035-bdf5-4c5a-94d8-f8438f6f0567	2024-08-27	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	86cfb84c-dcd3-b229-e053-2a91aa0aed5c	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Padagis Israel Pharmaceuticals Ltd	e630aa3d-11a6-4300-942a-cbdf2d016f77	2024-03-01	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Proficient Rx LP	e7f0e152-233a-492e-a297-7bf2c543c113	2022-05-02	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225 ndc (product): 63187-847

Additional Listing Data#

Finished product: Yes
Brand name base: Nystatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NYSTATIN	100000 [USP'U]/g

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
543546	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
e7f0e152-233a-492e-a297-7bf2c543c113	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63187-847-15	Nystatin	1 in 1 CARTON	CREAM	1	6
63187-847-15	Nystatin	15 g in 1 TUBE	CREAM	15	6
63187-847-30	Nystatin	1 in 1 CARTON	CREAM	1	6
63187-847-30	Nystatin	30 g in 1 TUBE	CREAM	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-847-15	GM - Gram	63187-847	b7f0061c-90e2-4e17-aa83-2cb649336cd2	1	2017-06-15
63187-847-30	GM - Gram	63187-847	42acb60e-e5c7-44f4-b02b-ff84919d4154	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-847	NYSTATIN CREAM [PROFICIENT RX LP]	6	Current NDC, Legacy NDC, 4 package rows	20220528_e7f0e152-233a-492e-a297-7bf2c543c113.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
543546	nystatin 100,000 UNT/GM Topical Cream	PSN	e7f0e152-233a-492e-a297-7bf2c543c113	6
543546	nystatin 100000 UNT/ML Topical Cream	SCD	e7f0e152-233a-492e-a297-7bf2c543c113	6
543546	nystatin 100,000 UNT/GM Topical Cream	SY	e7f0e152-233a-492e-a297-7bf2c543c113	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-847-15	63187084715	1 TUBE in 1 CARTON (63187-847-15) / 15 g in 1 TUBE	1 tube	2017-05-01	0000-00-00	No	No	Current
63187-847-30	63187084730	1 TUBE in 1 CARTON (63187-847-30) / 30 g in 1 TUBE	1 tube	2017-05-01	0000-00-00	No	No	Current