Nystatin

Product NDC: 55154-5786
11-digit product format: 551545786
Labeler code: 55154
Product ID: 55154-5786_3a01ce8f-67dd-4109-835d-a85bd544af3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NYSTATIN
Dosage form: SUSPENSION
Route: ORAL
Labeler: Cardinal Health
Application: ANDA203621
Marketing category: ANDA
Marketing start: 2016-02-01
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 [USP'U]/mL
Pharmacologic classes: Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	55154-5786		D	Discontinued by firm		2026-08-03
excluded package	package	55154-5786	55154-5786-5	D	Discontinued by firm		2026-08-03

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 · 24 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	55154-5786-5	`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	55154-5786-5	`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	55154-5786-5	`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	55154-5786-5	`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	55154-5786-5	`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	55154-5786-5	`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	55154-5786-5	`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	55154-5786-5	`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	55154-5786-5	`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	55154-5786-5	`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	55154-5786-5	`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	55154-5786-5	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A203621-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		2016-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203621-001	AA

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	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`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	A203621-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203621-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203621-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203621-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203621-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203621-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203621-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203621-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203621-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203621-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203621-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203621-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203621-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203621-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203621-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203621-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203621-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203621-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203621-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203621-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203621-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203621-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203621-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203621-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203621-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203621-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203621-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203621-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203621-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203621-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203621-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203621-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203621-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203621-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203621-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203621-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203621-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203621-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203621-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203621-001	AA	1	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	PAI Holdings, LLC dba PAI Pharma	28b4e26e-206a-4e8a-abfe-774b780e91c3	2026-07-21	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	Cardinal Health 107, LLC	d59098da-1395-49fb-9fd6-947bbbeed56f	2026-02-26	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	Major Pharmaceuticals	17b9e33d-da9c-467a-bbc4-9e257727f19a	2026-02-23	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	Cardinal Health 107, LLC	56aca0e2-8691-4701-beba-e2315524709f	2025-10-23	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	PAI Holdings, LLC dba PAI Pharma	05a8b8b6-3639-47b8-b7fc-47b105f5e6f9	2024-07-16	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	American Health Packaging	d8c251a6-d4da-4664-bff4-6868541d1178	2024-02-22	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	A-S Medication Solutions	cc3516cd-985c-489f-b4a1-8477876c5a97	2023-10-19	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	Pharmaceutical Associates, Inc.	31e3da10-5a7b-4bc5-8a4f-3e786b64c13a	2022-01-13	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BDF1O1C72E	NYSTATIN	1400-61-9	NYSTATIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-5786-5	55154578605	5 CUP, UNIT-DOSE in 1 BAG (55154-5786-5) > 5 mL in 1 CUP, UNIT-DOSE	2016-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Oral Suspension USP [100,000 units per mL]	Cardinal Health	2020-07-30	HUMAN PRESCRIPTION DRUG LABEL	2