Nystatin Topical Powder

Product NDC: 42806-178
11-digit product format: 428060178
Labeler code: 42806
Product ID: 42806-178_eb386427-9b1d-4b13-9e18-0f9cc00b4cb7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin Topical Powder
Dosage form: POWDER
Route: TOPICAL
Labeler: Epic Pharma, LLC
Application: ANDA210532
Marketing category: ANDA
Marketing start: 2018-05-02
Substance: NYSTATIN
Active strength: 100000 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 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
A210532-001	KLAYESTA	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT		2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210532-001	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 · 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	A210532-001	KLAYESTA	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210532-001	KLAYESTA	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210532-001	KLAYESTA	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210532-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2018-04-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210532-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210532-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210532-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210532-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210532-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210532-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210532-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210532-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210532-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210532-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210532-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210532-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210532-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210532-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210532-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210532-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210532-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210532-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210532-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210532-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210532-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210532-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210532-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210532-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210532-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210532-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210532-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210532-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210532-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210532-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210532-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210532-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210532-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210532-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210532-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210532-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210532-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210532-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210532-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210532-001	AT	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NYSTATIN	100000 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
646456	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
7f313a3b-7a4c-47fb-ad9f-e267514db527	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
42806-178-15	Nystatin Topical Powder	15 g in 1 BOTTLE	POWDER	15	3
42806-178-30	Nystatin Topical Powder	30 g in 1 BOTTLE	POWDER	30	3
42806-178-60	Nystatin Topical Powder	60 g in 1 BOTTLE	POWDER	60	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42806-178-15	GM - Gram	42806-178	9645ed68-b00f-40c3-b633-a0bedaccc814	1	2018-11-06
42806-178-30	GM - Gram	42806-178	db9b64df-c0b1-4cb0-8f21-6c402b05a4dd	1	2018-11-06
42806-178-60	GM - Gram	42806-178	8c4a0e64-b663-4716-91a0-6bbf7c650b16	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-178	NYSTATIN TOPICAL POWDER POWDER [EPIC PHARMA, LLC]	3	Current NDC, Legacy NDC, 3 package rows	20180502_7f313a3b-7a4c-47fb-ad9f-e267514db527.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KLAYESTA	NYSTATIN TOPICAL POWDER	Epic Pharma, LLC	0df13b1e-0e07-4123-a83a-1d7afb56170f	2025-12-17	Adverse reactions	Exact identifier application applno (ANDA): 210532 application number: ANDA210532
Nystatin Topical Powder	NYSTATIN TOPICAL POWDER	Epic Pharma, LLC	fb2a480e-0bb1-445e-bbb6-701dea6dc631	2023-08-10	Adverse reactions	Exact identifier application applno (ANDA): 210532 application number: ANDA210532
Nystatin Topical Powder	NYSTATIN TOPICAL POWDER	Epic Pharma, LLC	7f313a3b-7a4c-47fb-ad9f-e267514db527	2018-05-02	Adverse reactions	Exact identifier application applno (ANDA): 210532 application number: ANDA210532 ndc (product): 42806-178

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	7f313a3b-7a4c-47fb-ad9f-e267514db527	3
646456	nystatin 100 UNT/MG Topical Powder	SCD	7f313a3b-7a4c-47fb-ad9f-e267514db527	3
646456	nystatin 100,000 UNT/GM Topical Powder	SY	7f313a3b-7a4c-47fb-ad9f-e267514db527	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42806-178-15	42806017815	15 g in 1 BOTTLE (42806-178-15)	15 g	2018-05-02	0000-00-00	No	No	Current
42806-178-30	42806017830	30 g in 1 BOTTLE (42806-178-30)	30 g	2018-05-02	0000-00-00	No	No	Current
42806-178-60	42806017860	60 g in 1 BOTTLE (42806-178-60)	60 g	2018-05-02	0000-00-00	No	No	Current