Nystop

Product NDC: 63629-8697
11-digit product format: 636298697
Labeler code: 63629
Product ID: 63629-8697_bc867e0d-e4f6-47bc-b074-8417f83fbdc0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: POWDER
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA064118
Marketing category: ANDA
Marketing start: 1996-08-16
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 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
A064118-001	NYSTOP	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT		1996-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064118-001	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 · 41 observed 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	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT	1996-08-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064118-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064118-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064118-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064118-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064118-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064118-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064118-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064118-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064118-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064118-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064118-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064118-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064118-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064118-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064118-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064118-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064118-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064118-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064118-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064118-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064118-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064118-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064118-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064118-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064118-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064118-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064118-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064118-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064118-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064118-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064118-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064118-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064118-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064118-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064118-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064118-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064118-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064118-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064118-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064118-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nystop
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
261178	Internal RxNorm lookup
646456	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
87175864-9877-4e80-b870-907abb8ac289	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
63629-8697-1	Nystop	30 g in 1 BOTTLE, PLASTIC	POWDER	30		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8697-1	GM - Gram	63629-8697	e4bc5942-d7fd-44fa-b5dc-622beec6e56d	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8697	NYSTOP (NYSTATIN) POWDER [BRYANT RANCH PREPACK]	105	Current NDC, Legacy NDC, 1 package rows	20240814_87175864-9877-4e80-b870-907abb8ac289.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystop	NYSTATIN	Bryant Ranch Prepack	0bb31239-fb77-442a-a9ee-ba61b45e7e68	2026-07-14	Adverse reactions	Exact identifier application applno (ANDA): 064118 application number: ANDA064118
Nystop	NYSTATIN	Bryant Ranch Prepack	64041bdf-1207-47f6-93f3-bc4656a7d2ae	2025-10-21	Adverse reactions	Exact identifier application applno (ANDA): 064118 application number: ANDA064118
Nystop	NYSTATIN	Bryant Ranch Prepack	affea013-4f09-4e7d-a696-9f501d379af6	2025-10-21	Adverse reactions	Exact identifier application applno (ANDA): 064118 application number: ANDA064118
Nystatin	NYSTATIN	Northstar Rx LLC	9e6d0b0d-a68f-46aa-a707-3110ecb931b4	2025-09-30	Adverse reactions	Exact identifier application applno (ANDA): 064118 application number: ANDA064118
Nystop	NYSTATIN	Bryant Ranch Prepack	69ebb4dd-f45d-448d-97cd-3f8935493975	2025-08-26	Adverse reactions	Exact identifier application applno (ANDA): 064118 application number: ANDA064118
Nystop	NYSTATIN	Padagis US LLC	e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f	2024-10-31	Adverse reactions	Exact identifier application applno (ANDA): 064118 application number: ANDA064118
Nystop	NYSTATIN	Bryant Ranch Prepack	87175864-9877-4e80-b870-907abb8ac289	2024-03-22	Adverse reactions	Exact identifier application applno (ANDA): 064118 application number: ANDA064118 ndc (product): 63629-8697
Nystop	NYSTATIN	Bryant Ranch Prepack	5bce98a3-2964-4edc-b8da-8a46dafadf5e	2024-01-11	Adverse reactions	Exact identifier application applno (ANDA): 064118 application number: ANDA064118

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
646456	nystatin 100,000 UNT/GM Topical Powder	PSN	87175864-9877-4e80-b870-907abb8ac289	105
261178	NYSTOP 100,000 UNT/GM Topical Powder	PSN	87175864-9877-4e80-b870-907abb8ac289	105
261178	nystatin 100 UNT/MG Topical Powder [Nystop]	SBD	87175864-9877-4e80-b870-907abb8ac289	105
646456	nystatin 100 UNT/MG Topical Powder	SCD	87175864-9877-4e80-b870-907abb8ac289	105
646456	nystatin 100,000 UNT/GM Topical Powder	SY	87175864-9877-4e80-b870-907abb8ac289	105
261178	Nystop 100 UNT/MG Topical Powder	SY	87175864-9877-4e80-b870-907abb8ac289	105
261178	Nystop 100,000 UNT/GM Topical Powder	SY	87175864-9877-4e80-b870-907abb8ac289	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8697-1	63629869701	30 g in 1 BOTTLE, PLASTIC (63629-8697-1)	30 g	1996-08-16	0000-00-00	No	No	Current