Nystatin

Product NDC: 50090-1740
11-digit product format: 500901740
Labeler code: 50090
Product ID: 50090-1740_8d9b172d-a817-43b1-9cd9-24243b311f28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nystatin
Dosage form: SUSPENSION
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA062512
Marketing category: ANDA
Marketing start: 1995-04-15
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
A062512-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062512-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`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	A062512-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062512-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062512-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062512-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062512-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062512-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062512-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062512-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062512-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062512-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062512-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062512-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062512-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062512-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062512-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062512-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062512-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062512-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062512-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062512-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062512-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062512-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062512-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062512-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062512-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062512-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062512-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062512-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062512-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062512-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062512-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062512-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062512-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062512-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062512-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062512-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062512-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062512-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062512-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062512-001	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
e069d495-7f1a-4970-8f4d-aa93d124b3fc	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
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
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
50090-1740-0	2023-02-07	C162847	48780-1	f386c64a-320b-0266-e053-dadaa90a7c1a	NYSTATIN ORAL SUSPENSION, USP
50090-1740-0	2023-01-30	C162847	48780-1	f386c64a-320b-0266-e053-dadaa90a7c1a	NYSTATIN ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1740-0	Nystatin	60 mL in 1 BOTTLE, GLASS	SUSPENSION	60		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1740-0	ML - Milliliter	50090-1740	35986bda-2366-4abb-8c3a-cc6529ac50d1	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1740	NYSTATIN SUSPENSION [A-S MEDICATION SOLUTIONS]	9	Current NDC, Legacy NDC, 1 package rows	20230208_e069d495-7f1a-4970-8f4d-aa93d124b3fc.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 Oral Suspension	NYSTATIN	Xttrium Laboratories, Inc.	4a670371-d373-1ba6-e063-6394a90a13b6	2026-02-06	Adverse reactions	Exact identifier application applno (ANDA): 062512 application number: ANDA062512
Nystatin	NYSTATIN	A-S Medication Solutions	e069d495-7f1a-4970-8f4d-aa93d124b3fc	2023-02-04	Adverse reactions	Exact identifier application applno (ANDA): 062512 application number: ANDA062512 ndc (product): 50090-1740

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	e069d495-7f1a-4970-8f4d-aa93d124b3fc	9
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	e069d495-7f1a-4970-8f4d-aa93d124b3fc	9
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	e069d495-7f1a-4970-8f4d-aa93d124b3fc	9
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	e069d495-7f1a-4970-8f4d-aa93d124b3fc	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1740-0	50090174000	60 mL in 1 BOTTLE, GLASS (50090-1740-0)	60 ml	2015-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NYSTATIN ORAL SUSPENSION, USP	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	9