Nystatin

Product NDC: 72162-1385
11-digit product format: 721621385
Labeler code: 72162
Product ID: 72162-1385_ea5d13f8-38cd-4010-a78f-ccafe2002c4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: CREAM
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA062225
Marketing category: ANDA
Marketing start: 2006-09-21
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
A062225-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	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
A062225-001	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	Source SHA-256
2026-08-18 06:07:40	2026-07	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062225-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`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	A062225-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062225-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062225-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062225-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062225-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062225-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062225-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062225-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062225-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062225-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062225-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062225-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062225-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062225-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062225-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062225-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062225-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062225-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062225-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062225-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062225-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062225-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062225-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062225-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062225-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062225-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062225-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062225-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062225-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062225-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062225-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062225-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062225-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062225-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062225-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062225-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062225-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062225-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062225-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062225-001	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
cc8f9a06-cd1b-40e9-bc22-7e19f6d89b83	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
72162-1385-2	Nystatin	15 g in 1 TUBE	CREAM	15	102
72162-1385-2	Nystatin	1 in 1 CARTON	CREAM	1	102
72162-1385-3	Nystatin	30 g in 1 TUBE	CREAM	30	102
72162-1385-3	Nystatin	1 in 1 CARTON	CREAM	1	102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1385-2	GM - Gram	72162-1385	6788cf63-1a73-4bbd-80ea-7570bc441da9	1	2025-05-14
72162-1385-3	GM - Gram	72162-1385	66263277-ff59-4dc8-bb52-2bf450ec0714	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1385	NYSTATIN CREAM [BRYANT RANCH PREPACK]	100	Current NDC, 4 package rows	20250406_cc8f9a06-cd1b-40e9-bc22-7e19f6d89b83.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycostatin	NYSTATIN	Direct_Rx	f1857ac0-806c-4a7e-e053-2995a90abbc0	2026-03-17	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	A-S Medication Solutions	f1b13a36-c349-4e26-a322-3ec02c610155	2026-03-16	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Bryant Ranch Prepack	b71356cf-7b6e-4ca0-9571-c80fd0d846cb	2025-10-23	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Bryant Ranch Prepack	840eebe8-5de2-40c5-acfd-03a98b2e790e	2025-09-23	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Bryant Ranch Prepack	cc8f9a06-cd1b-40e9-bc22-7e19f6d89b83	2025-04-02	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225 ndc (product): 72162-1385
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	6599b544-60bd-ab30-e053-2a91aa0a67b6	2024-11-20	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	A-S Medication Solutions	f410ba07-9183-40a8-a2a6-46d3e9761470	2024-11-06	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Bryant Ranch Prepack	b69d9035-bdf5-4c5a-94d8-f8438f6f0567	2024-08-27	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	NuCare Pharmaceuticals,Inc.	86cfb84c-dcd3-b229-e053-2a91aa0aed5c	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Padagis Israel Pharmaceuticals Ltd	e630aa3d-11a6-4300-942a-cbdf2d016f77	2024-03-01	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225
Nystatin	NYSTATIN	Proficient Rx LP	e7f0e152-233a-492e-a297-7bf2c543c113	2022-05-02	Adverse reactions	Exact identifier application applno (ANDA): 062225 application number: ANDA062225

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	cc8f9a06-cd1b-40e9-bc22-7e19f6d89b83	102
543546	nystatin 100000 UNT/ML Topical Cream	SCD	cc8f9a06-cd1b-40e9-bc22-7e19f6d89b83	102
543546	nystatin 100,000 UNT/GM Topical Cream	SY	cc8f9a06-cd1b-40e9-bc22-7e19f6d89b83	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1385-2	72162138502	1 TUBE in 1 CARTON (72162-1385-2) / 15 g in 1 TUBE	1 tube	2025-04-02	No	No	Current
72162-1385-3	72162138503	1 TUBE in 1 CARTON (72162-1385-3) / 30 g in 1 TUBE	1 tube	2025-04-02	No	No	Current