Nystatin

Product NDC: 45802-048
11-digit product format: 458020048
Labeler code: 45802
Product ID: 45802-048_d0882d4c-19ef-45d3-99c2-2697b1d213d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA062472
Marketing category: ANDA
Marketing start: 2006-09-15
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
A062472-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT		1984-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062472-001	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.

Product history page 1 of 2 · 41 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	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062472-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	1984-02-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062472-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062472-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062472-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062472-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062472-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062472-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062472-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062472-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062472-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062472-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062472-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062472-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062472-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062472-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062472-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062472-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062472-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062472-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062472-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062472-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062472-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062472-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062472-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062472-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062472-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062472-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062472-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062472-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062472-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062472-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062472-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062472-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062472-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062472-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062472-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062472-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062472-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062472-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062472-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062472-001	AT	1	`cb3db0bc1861…`

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
884308	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
6c091c66-2e4d-4412-b7bf-35315dc8152f	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
45802-048-11	Nystatin	1 in 1 CARTON	OINTMENT	1	10
45802-048-11	Nystatin	30 g in 1 TUBE	OINTMENT	30	10
45802-048-35	Nystatin	1 in 1 CARTON	OINTMENT	1	10
45802-048-35	Nystatin	15 g in 1 TUBE	OINTMENT	15	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-048-11	GM - Gram	45802-048	1ee4e49b-b21e-4d04-a4c2-3f7e3d82747b	1	2012-07-24
45802-048-35	GM - Gram	45802-048	7b60fa1f-03d4-4706-a26f-6c900db3cad8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NYSTATIN	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN OINTMENT [PERRIGO NEW YORK INC]	5
NYSTATIN	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN OINTMENT [PERRIGO NEW YORK INC]	5
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	NYSTATIN OINTMENT [PERRIGO NEW YORK INC]	5
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	NYSTATIN OINTMENT [PERRIGO NEW YORK INC]	5
NYSTATIN	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	2
NYSTATIN	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	2
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	NYSTATIN OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	NYSTATIN OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-048	NYSTATIN OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]	10	Current NDC, Legacy NDC, 4 package rows	20250125_6c091c66-2e4d-4412-b7bf-35315dc8152f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Bryant Ranch Prepack	72dc2b60-29a4-48a8-848a-1a5086cfdd58	2025-04-03	Adverse reactions	Exact identifier application applno (ANDA): 062472 application number: ANDA062472
Nystatin	NYSTATIN	Padagis Israel Pharmaceuticals Ltd	6c091c66-2e4d-4412-b7bf-35315dc8152f	2025-01-23	Adverse reactions	Exact identifier application applno (ANDA): 062472 application number: ANDA062472 ndc (product): 45802-048

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
884308	nystatin 100,000 UNT/GM Topical Ointment	PSN	6c091c66-2e4d-4412-b7bf-35315dc8152f	10
884308	nystatin 100 UNT/MG Topical Ointment	SCD	6c091c66-2e4d-4412-b7bf-35315dc8152f	10
884308	nystatin 100,000 UNT/GM Topical Ointment	SY	6c091c66-2e4d-4412-b7bf-35315dc8152f	10
884308	nystatin 100,000 UNT/GM Topical Ointment	PSN	0ee89f89-e90d-4706-9fa5-a61b5fde4470	5
884308	nystatin 100 UNT/MG Topical Ointment	SCD	0ee89f89-e90d-4706-9fa5-a61b5fde4470	5
884308	nystatin 100,000 UNT/GM Topical Ointment	SY	0ee89f89-e90d-4706-9fa5-a61b5fde4470	5
884308	nystatin 100,000 UNT/GM Topical Ointment	PSN	72dc2b60-29a4-48a8-848a-1a5086cfdd58	2
884308	nystatin 100 UNT/MG Topical Ointment	SCD	72dc2b60-29a4-48a8-848a-1a5086cfdd58	2
884308	nystatin 100,000 UNT/GM Topical Ointment	SY	72dc2b60-29a4-48a8-848a-1a5086cfdd58	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-048-11	45802004811	1 TUBE in 1 CARTON (45802-048-11) / 30 g in 1 TUBE	1 tube	2006-11-08	0000-00-00	No	No	Current
45802-048-35	45802004835	1 TUBE in 1 CARTON (45802-048-35) / 15 g in 1 TUBE	1 tube	2006-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Ointment USP	Bryant Ranch Prepack	2025-04-03	HUMAN PRESCRIPTION DRUG LABEL	2
Nystatin Ointment USP	Padagis Israel Pharmaceuticals Ltd	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	10
Nystatin Ointment USP	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
NYSTATIN OINTMENT USP	A-S Medication Solutions	2022-10-16	HUMAN PRESCRIPTION DRUG LABEL	14
NYSTATIN OINTMENT USP	Preferred Pharmaceuticals, Inc.	2022-09-15	HUMAN PRESCRIPTION DRUG LABEL	8