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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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		2026-08-17
excluded package	package	42254-303	42254-303-15	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-303-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-303-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-303-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-303-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-303-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-303-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-303-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-303-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-303-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-303-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-303-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-303-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-303-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-303-15	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-303-15	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-303-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-303-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-303-15	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-303-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-303-15	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-303-15	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-303-15	`110d247fa046…`	`a55b01930146…`

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
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.

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065203-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	RS	2004-07-15	`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	A065203-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065203-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065203-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065203-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065203-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065203-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065203-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065203-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065203-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065203-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065203-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065203-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065203-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065203-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065203-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065203-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065203-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065203-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065203-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065203-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065203-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065203-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065203-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065203-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065203-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065203-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065203-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065203-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065203-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065203-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065203-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065203-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065203-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065203-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065203-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065203-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065203-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065203-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065203-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065203-001	AT	1	`e64feba35796…`

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

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 · 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

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