Nystatin

Product NDC: 63187-703
11-digit product format: 631870703
Labeler code: 63187
Product ID: 63187-703_bbcffae3-b609-478f-9702-6ae78847cdba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: CREAM
Route: TOPICAL
Labeler: Proficient Rx LP
Application: ANDA064022
Marketing category: ANDA
Marketing start: 1993-01-28
Substance: NYSTATIN
Active strength: 100000 [USP'U]/g
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
A064022-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064022-001	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.

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	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064022-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	RS	1993-01-29	`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	A064022-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064022-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064022-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064022-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064022-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064022-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064022-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064022-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064022-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064022-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064022-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064022-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064022-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064022-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064022-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064022-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064022-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064022-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064022-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064022-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064022-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064022-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064022-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064022-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064022-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064022-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064022-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064022-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064022-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064022-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064022-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064022-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064022-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064022-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064022-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064022-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064022-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064022-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064022-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064022-001	AT	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]/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
5ef15e1c-66dc-4858-8552-d83e42c3883e	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	SPL version
63187-703-15	Nystatin	15 g in 1 TUBE	CREAM	15	3
63187-703-15	Nystatin	1 in 1 CARTON	CREAM	1	3
63187-703-30	Nystatin	30 g in 1 TUBE	CREAM	30	3
63187-703-30	Nystatin	1 in 1 CARTON	CREAM	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-703	NYSTATIN CREAM [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 4 package rows	20191121_5ef15e1c-66dc-4858-8552-d83e42c3883e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Sun Pharmaceutical Industries, Inc.	4d845b3f-ca26-4c47-b424-b6d783cc10e5	2025-07-03	Adverse reactions	Exact identifier application applno (ANDA): 064022 application number: ANDA064022
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	cf6b7c68-7769-1808-e053-2995a90aa426	2025-02-10	Adverse reactions	Exact identifier application applno (ANDA): 064022 application number: ANDA064022
NYSTATIN	NYSTATIN	DIRECT RX	cd387929-5b72-e3c0-e053-2a95a90adb22	2025-01-20	Adverse reactions	Exact identifier application applno (ANDA): 064022 application number: ANDA064022
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	57825c04-dcb5-b76d-e053-2991aa0a4c1d	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 064022 application number: ANDA064022
Nystatin	NYSTATIN	Proficient Rx LP	5ef15e1c-66dc-4858-8552-d83e42c3883e	2019-11-01	Adverse reactions	Exact identifier application applno (ANDA): 064022 application number: ANDA064022 ndc (product): 63187-703

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	5ef15e1c-66dc-4858-8552-d83e42c3883e	3
543546	nystatin 100000 UNT/ML Topical Cream	SCD	5ef15e1c-66dc-4858-8552-d83e42c3883e	3
543546	nystatin 100,000 UNT/GM Topical Cream	SY	5ef15e1c-66dc-4858-8552-d83e42c3883e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-703-15	63187070315	1 TUBE in 1 CARTON (63187-703-15) / 15 g in 1 TUBE	1 tube	2016-06-01	0000-00-00	No	No	Current
63187-703-30	63187070330	1 TUBE in 1 CARTON (63187-703-30) / 30 g in 1 TUBE	1 tube	2016-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Cream USP, 100,000 units per gram	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3