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

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 Identifiers#

Field, Values table
Field	Values
Unii	BDF1O1C72E
Rxcui	543546

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	Strength	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

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