Nystatin

Product NDC: 0121-1045
11-digit product format: 001211045
Labeler code: 0121
Product ID: 0121-1045_4901e044-ed1c-4f55-add3-c33e1399f91a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NYSTATIN
Dosage form: SUSPENSION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA203621
Marketing category: ANDA
Marketing start: 2024-06-21
Substance: NYSTATIN
Active strength: 100000 [USP'U]/mL
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
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 · 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	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2016-01-07	`caaa826d4ba7…`
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…`

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	A203621-001	AA	1	`caaa826d4ba7…`
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…`

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]/mL

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
312055	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
05a8b8b6-3639-47b8-b7fc-47b105f5e6f9	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
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
e57b6340-9387-3f9a-7307-511c81791375	Product name	3	20221214
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
544f8e8d-6389-eeeb-9586-aa447c08dcc7	Product name	5	20210614
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
854ec07b-1cd7-a5db-235a-7aa24d3cf97a	Product name	3	20180628
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
0121-1045-16	Nystatin	473 mL in 1 BOTTLE	SUSPENSION	473		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1045-16	ML - Milliliter	0121-1045	e343bae4-f68c-4ae6-bad6-4d96cd809527	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-1045	NYSTATIN SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]	1	Current NDC, 1 package rows	20240717_05a8b8b6-3639-47b8-b7fc-47b105f5e6f9.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 · 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 ndc (product): 0121-1045
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	2e7fadda-5f16-4be6-b6bb-985fafe3a1f3	3
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	2e7fadda-5f16-4be6-b6bb-985fafe3a1f3	3
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	2e7fadda-5f16-4be6-b6bb-985fafe3a1f3	3
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	2e7fadda-5f16-4be6-b6bb-985fafe3a1f3	3
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	05a8b8b6-3639-47b8-b7fc-47b105f5e6f9	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	05a8b8b6-3639-47b8-b7fc-47b105f5e6f9	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	05a8b8b6-3639-47b8-b7fc-47b105f5e6f9	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	05a8b8b6-3639-47b8-b7fc-47b105f5e6f9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0121-1045-16	00121104516	473 mL in 1 BOTTLE (0121-1045-16)	473 ml	2024-06-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Oral Suspension USP [100,000 units per mL]	ATLANTIC BIOLOGICALS CORP.	2025-05-23	HUMAN PRESCRIPTION DRUG LABEL	3
Nystatin Oral Suspension USP [100,000 units per mL]	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-07-16	HUMAN PRESCRIPTION DRUG LABEL	1