NYSTATIN

Product NDC: 63629-2493
Requested package NDC: 63629-2493-1
11-digit product format: 636292493
Labeler code: 63629
Product ID: 63629-2493_4d605e1a-4670-4080-bc99-7c91a1f5bcd5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NYSTATIN
Dosage form: SUSPENSION
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA062832
Marketing category: ANDA
Marketing start: 2020-08-14
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 [USP'U]/mL
Pharmacologic classes: Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-2493	63629-2493-1	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
A062832-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1991-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062832-001	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 · 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	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`cb3db0bc1861…`

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	A062832-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062832-001	AA	1	`31067a03dcf5…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062832-001	AA	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062832-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062832-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062832-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062832-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062832-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062832-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062832-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A062832-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062832-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062832-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062832-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062832-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062832-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062832-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062832-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062832-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062832-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062832-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062832-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062832-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062832-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062832-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062832-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062832-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062832-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062832-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062832-001	AA	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2493-1	ML - Milliliter	63629-2493	6dc991b0-f3cf-4e32-9d24-234d6533018f	1	2021-04-08

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	Kesin Pharma Corporation	50737729-a4a4-e747-e063-6394a90adcc5	2026-06-30	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Bryant Ranch Prepack	4f6f59fb-ae7d-48e5-b23e-a1d92160974f	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Kesin Pharma Corporation	43817169-bbe8-58ee-e063-6294a90a1250	2025-12-11	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Kanchan Healthcare Inc	90a52c3f-3ef7-4f3b-9fe5-40af408e9f2a	2025-09-12	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Bryant Ranch Prepack	b06c65cd-5b65-4bc6-aae9-b9381c6f1948	2023-01-26	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BDF1O1C72E	NYSTATIN	1400-61-9	NYSTATIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2493-1	63629249301	1 BOTTLE, DROPPER in 1 CARTON (63629-2493-1) > 60 mL in 1 BOTTLE, DROPPER	2020-08-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	104