Nystatin

Product NDC: 62135-813
11-digit product format: 621350813
Labeler code: 62135
Product ID: 62135-813_4c47b825-6b93-307f-e063-6394a90a2b7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: NDA050299
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1971-04-14
Substance: NYSTATIN
Active strength: 100000 U/mL
Pharmacologic classes: Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
N050299-001	NILSTAT	NYSTATIN	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AA	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050299-001	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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AA	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050299-001	NILSTAT	100,000 UNITS/ML	SUSPENSION / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050299-001	NILSTAT	100,000 UNITS/ML	SUSPENSION / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050299-001	NILSTAT	100,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050299-001	AA	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050299-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nystatin
Listing expiration: 2027-12-31

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
9954118e-abe6-4388-98c9-4473d39b2e28	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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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	Strength	SPL version
62135-813-46	Nystatin	60 mL in 1 BOTTLE	SUSPENSION	60		7
62135-813-47	Nystatin	473 mL in 1 BOTTLE	SUSPENSION	473		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-813-05	ML - Milliliter	62135-813	fe55caaf-54d5-488e-9fab-cf7d96fdb8fa	1	2024-12-10
62135-813-24	ML - Milliliter	62135-813	e94dc51c-459e-4f1d-9486-c9ca3a437044	1	2024-12-10
62135-813-46	ML - Milliliter	62135-813	62fd1cad-1d78-46dc-ba8a-004db1afc171	1	2024-08-12
62135-813-47	ML - Milliliter	62135-813	831c03c6-b8d6-49bb-84d2-af8f3052a054	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-813	NYSTATIN SUSPENSION [CHARTWELL RX, LLC]	5	Current NDC, 2 package rows	20250327_9954118e-abe6-4388-98c9-4473d39b2e28.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Chartwell RX, LLC	9954118e-abe6-4388-98c9-4473d39b2e28	2026-03-05	Adverse reactions	Exact identifier application applno (NDA): 050299 application number: NDA050299 ndc (product): 62135-813
Nystatin	NYSTATIN	Chartwell Governmental & Specialty RX, LLC	88a0a22e-8d6b-42aa-b225-2d57fb5b3a97	2025-11-12	Adverse reactions	Exact identifier application applno (NDA): 050299 application number: NDA050299

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	9954118e-abe6-4388-98c9-4473d39b2e28	7
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	9954118e-abe6-4388-98c9-4473d39b2e28	7
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	9954118e-abe6-4388-98c9-4473d39b2e28	7
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	9954118e-abe6-4388-98c9-4473d39b2e28	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-813-46	62135081346	60 mL in 1 BOTTLE (62135-813-46)	60 ml	2024-06-27	No	No	Current
62135-813-47	62135081347	473 mL in 1 BOTTLE (62135-813-47)	473 ml	2024-04-10	No	No	Current