Nystatin

Product NDC: 70166-331
Requested package NDC: 70166-331-05
11-digit product format: 701660331
Labeler code: 70166
Product ID: 70166-331_7e97521f-a8f9-4bf7-e053-2991aa0a74e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Lohxa
Application: ANDA062876
Marketing category: ANDA
Marketing start: 2019-01-03
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	70166-331	70166-331-05	I	Inactivated by FDA		2026-08-03

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
A062876-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL			1988-02-29

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
2025-01-19 17:59 UTC	2025-01	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1988-02-29	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A062876-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1988-02-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC	2025-01	A062876-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062876-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062876-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062876-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062876-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062876-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062876-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062876-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062876-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062876-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062876-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062876-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062876-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062876-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062876-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062876-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062876-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062876-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062876-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062876-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062876-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062876-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062876-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062876-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062876-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062876-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062876-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062876-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062876-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062876-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062876-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062876-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062876-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062876-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062876-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70166-331-05	2024-01-30	C162847	48780-1	1030e365-5427-111a-e063-dadaa90a10e2	Nystatin Oral Suspension, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70166-331-05	Nystatin	50 in 1 CARTON	SUSPENSION	50		1
70166-331-05	Nystatin	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70166-331	NYSTATIN SUSPENSION [LOHXA]	1	Legacy NDC, 2 package rows	20190104_a0540f97-18a2-4dd5-b3a8-a899c3831f51.zip

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
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	a0540f97-18a2-4dd5-b3a8-a899c3831f51	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	a0540f97-18a2-4dd5-b3a8-a899c3831f51	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	a0540f97-18a2-4dd5-b3a8-a899c3831f51	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	a0540f97-18a2-4dd5-b3a8-a899c3831f51	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70166-331-05	70166033105	50 CUP, UNIT-DOSE in 1 CARTON (70166-331-05) > 5 mL in 1 CUP, UNIT-DOSE	2019-01-03	0000-00-00	No	No	Current