Nystatin

Product NDC: 67296-1519
11-digit product format: 672961519
Labeler code: 67296
Product ID: 67296-1519_4922a3ab-05b8-2ff2-e063-6294a90a9fd4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: CREAM
Route: TOPICAL
Labeler: RedPharm Drug, Inc
Application: ANDA212557
Marketing category: ANDA
Marketing start: 2019-07-24
Substance: NYSTATIN
Active strength: 100000 U/g
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 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
A212557-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT		2019-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212557-001	AT

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.

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	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212557-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212557-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212557-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212557-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212557-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212557-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212557-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212557-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212557-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212557-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212557-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212557-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212557-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212557-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212557-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212557-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212557-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212557-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212557-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212557-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212557-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212557-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212557-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212557-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212557-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212557-001	AT	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212557-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212557-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212557-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212557-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212557-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212557-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212557-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212557-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212557-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212557-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212557-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212557-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212557-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212557-001	AT	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/g

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
543546	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
f4c298d5-b012-7b56-e053-2a95a90a3d55	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
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
67296-1519-1	Nystatin	15 g in 1 TUBE	CREAM	15		4
67296-1519-3	Nystatin	30 g in 1 TUBE	CREAM	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1519	NYSTATIN CREAM [REDPHARM DRUG, INC]	2	Current NDC, 2 package rows	20240809_f4c298d5-b012-7b56-e053-2a95a90a3d55.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Bryant Ranch Prepack	2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc	2026-07-09	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	Torrent Pharmaceuticals Limited	559b5bd4-3564-4437-8d0a-fa3a972f8b83	2026-05-01	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	RedPharm Drug, Inc	f4c298d5-b012-7b56-e053-2a95a90a3d55	2026-01-24	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557 ndc (product): 67296-1519
Nystatin	NYSTATIN	Preferred Pharmaceuticals Inc.	d92f67a7-dcae-41c0-9a35-dbafa2361170	2025-08-28	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	A-S Medication Solutions	65167baa-29f8-44d3-b2d2-935c862d463e	2024-10-16	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	Proficient Rx LP	8566c432-741f-4af7-91d7-1b7668ce5e95	2023-12-01	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557

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
543546	nystatin 100,000 UNT/GM Topical Cream	PSN	f4c298d5-b012-7b56-e053-2a95a90a3d55	4
543546	nystatin 100000 UNT/ML Topical Cream	SCD	f4c298d5-b012-7b56-e053-2a95a90a3d55	4
543546	nystatin 100,000 UNT/GM Topical Cream	SY	f4c298d5-b012-7b56-e053-2a95a90a3d55	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-1519-1	67296151901	15 g in 1 TUBE (67296-1519-1)	15 g	2019-07-24	No	No	Current
67296-1519-3	67296151903	30 g in 1 TUBE (67296-1519-3)	30 g	2019-07-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Cream USP, 100,000 units per gram FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE	RedPharm Drug, Inc	2026-01-24	HUMAN PRESCRIPTION DRUG LABEL	4