NYSTATIN

Product NDC: 81033-015
11-digit product format: 810330015
Labeler code: 81033
Product ID: 81033-015_45b08d8c-c755-d45b-e063-6394a90aa4c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NYSTATIN
Dosage form: SUSPENSION
Route: ORAL
Labeler: Kesin Pharma Corporation
Application: ANDA062832
Marketing category: ANDA
Marketing start: 2020-08-14
Substance: NYSTATIN
Active strength: 100000 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 44.

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
A062832-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1991-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062832-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A062832-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062832-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062832-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062832-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062832-001	AA	1	`31067a03dcf5…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062832-001	AA	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062832-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062832-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062832-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062832-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062832-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062832-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062832-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A062832-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062832-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062832-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062832-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062832-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062832-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062832-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062832-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062832-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062832-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062832-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062832-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062832-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062832-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062832-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062832-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062832-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062832-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062832-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062832-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: NYSTATIN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NYSTATIN	100000 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
43817169-bbe8-58ee-e063-6294a90a1250	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81033-015-01	NYSTATIN	100 in 1 CASE	SUSPENSION	100	2
81033-015-05	NYSTATIN	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	5	2
81033-015-54	NYSTATIN	50 in 1 CARTON	SUSPENSION	50	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-015-01	ML - Milliliter	81033-015	2cfb8a81-2eb0-4024-8476-284f8d063336	1	2026-03-17
81033-015-05	ML - Milliliter	81033-015	49867bf3-a8d3-4975-bb87-7df548767592	1	2026-03-17
81033-015-54	ML - Milliliter	81033-015	24ab3546-05de-4da6-a3a5-dadae4b1265b	1	2026-03-17

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NYSTATIN	NYSTATIN	Kesin Pharma Corporation	50737729-a4a4-e747-e063-6394a90adcc5	2026-06-30	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832 ndc (product): 81033-015
NYSTATIN	NYSTATIN	Bryant Ranch Prepack	4f6f59fb-ae7d-48e5-b23e-a1d92160974f	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Kesin Pharma Corporation	43817169-bbe8-58ee-e063-6294a90a1250	2025-12-11	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832 ndc (product): 81033-015
NYSTATIN	NYSTATIN	Bryant Ranch Prepack	b06c65cd-5b65-4bc6-aae9-b9381c6f1948	2023-01-26	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832

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	43817169-bbe8-58ee-e063-6294a90a1250	2
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	43817169-bbe8-58ee-e063-6294a90a1250	2
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	43817169-bbe8-58ee-e063-6294a90a1250	2
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	43817169-bbe8-58ee-e063-6294a90a1250	2
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	50737729-a4a4-e747-e063-6394a90adcc5	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	50737729-a4a4-e747-e063-6394a90adcc5	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	50737729-a4a4-e747-e063-6394a90adcc5	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	50737729-a4a4-e747-e063-6394a90adcc5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81033-015-01	81033001501	100 CUP, UNIT-DOSE in 1 CASE (81033-015-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05)		2025-11-24	No	No	Current
81033-015-05	81033001505	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical
81033-015-16	81033001516	473 mL in 1 BOTTLE (81033-015-16)	473 ml	2026-06-30	No	No	Current
81033-015-54	81033001554	50 CUP, UNIT-DOSE in 1 CARTON (81033-015-54) / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05)		2025-11-24	No	No	Current
81033-015-60	81033001560	1 BOTTLE in 1 CARTON (81033-015-60) / 60 mL in 1 BOTTLE	1 bottle	2026-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NYSTATIN ORAL SUSPENSION, USP Rx only	Kesin Pharma Corporation	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	1
NYSTATIN ORAL SUSPENSION, USP Rx only	Kesin Pharma Corporation	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	2