Nystatin

Product NDC: 0121-0868
Requested package NDC: 0121-0868-40
11-digit product format: 001210868
Labeler code: 0121
Product ID: 0121-0868_15a142a2-4bb9-444e-8b22-73acf9f91f3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NYSTATIN
Dosage form: SUSPENSION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA203621
Marketing category: ANDA
Marketing start: 2020-07-17
Substance: NYSTATIN
Active strength: 100000 [USP'U]/mL
Pharmacologic classes: Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0121-0868	0121-0868-40	D	Discontinued by firm		2026-07-31

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
A203621-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		2016-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203621-001	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.

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
2026-08-01 22:54:32	2026-06	A203621-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		2016-01-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A203621-001	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Nystatin	NYSTATIN	PAI Holdings, LLC dba PAI Pharma	28b4e26e-206a-4e8a-abfe-774b780e91c3	2026-07-21	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621 ndc (package): 0121-0868-40 ndc (product): 0121-0868 ndc11 (package): 00121086840
Nystatin	NYSTATIN	Cardinal Health 107, LLC	d59098da-1395-49fb-9fd6-947bbbeed56f	2026-02-26	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	Major Pharmaceuticals	17b9e33d-da9c-467a-bbc4-9e257727f19a	2026-02-23	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	Cardinal Health 107, LLC	56aca0e2-8691-4701-beba-e2315524709f	2025-10-23	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	PAI Holdings, LLC dba PAI Pharma	05a8b8b6-3639-47b8-b7fc-47b105f5e6f9	2024-07-16	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	American Health Packaging	d8c251a6-d4da-4664-bff4-6868541d1178	2024-02-22	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	A-S Medication Solutions	cc3516cd-985c-489f-b4a1-8477876c5a97	2023-10-19	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621
Nystatin	NYSTATIN	Pharmaceutical Associates, Inc.	31e3da10-5a7b-4bc5-8a4f-3e786b64c13a	2022-01-13	Adverse reactions	Exact identifier application applno (ANDA): 203621 application number: ANDA203621

Additional Listing Data#

Finished product: Yes
Brand name base: Nystatin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NYSTATIN	100000 [USP'U]/mL

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
312055	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
28b4e26e-206a-4e8a-abfe-774b780e91c3	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
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
e57b6340-9387-3f9a-7307-511c81791375	Product name	3	20221214
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
544f8e8d-6389-eeeb-9586-aa447c08dcc7	Product name	5	20210614
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
854ec07b-1cd7-a5db-235a-7aa24d3cf97a	Product name	3	20180628
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
0121-0868-00	Nystatin	10 in 1 CASE	SUSPENSION	10	8
0121-0868-00	Nystatin	10 in 1 TRAY	SUSPENSION	10	8
0121-0868-02	Nystatin	60 mL in 1 BOTTLE, DROPPER	SUSPENSION	60	8
0121-0868-05	Nystatin	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	5	8
0121-0868-16	Nystatin	473 mL in 1 BOTTLE	SUSPENSION	473	8
0121-0868-40	Nystatin	4 in 1 CASE	SUSPENSION	4	8
0121-0868-40	Nystatin	10 in 1 TRAY	SUSPENSION	10	8
0121-0868-50	Nystatin	10 in 1 TRAY	SUSPENSION	10	8
0121-0868-50	Nystatin	5 in 1 CASE	SUSPENSION	5	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0868-00	ML - Milliliter	0121-0868	b068ec19-d240-4824-a64e-273e938ce598	1	2020-08-06
0121-0868-02	ML - Milliliter	0121-0868	4ae76eca-a726-49f6-84c8-d8d6c9ee4765	1	2020-08-06
0121-0868-05	ML - Milliliter	0121-0868	e2af12f7-3a29-4bd8-a874-d5e0c50d9a67	1	2020-08-06
0121-0868-16	ML - Milliliter	0121-0868	f3d006ad-0cdc-4f80-983f-3450ba73191b	1	2020-08-06
0121-0868-40	ML - Milliliter	0121-0868	831de8ef-a458-4bf3-94d7-fec8d021b6f4	1	2020-08-06
0121-0868-50	ML - Milliliter	0121-0868	2020f77a-6e92-4fc6-8c28-4e8675279aa3	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0868	NYSTATIN SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]	8	Current NDC, Legacy NDC, 9 package rows	20240906_28b4e26e-206a-4e8a-abfe-774b780e91c3.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	28b4e26e-206a-4e8a-abfe-774b780e91c3	8
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	28b4e26e-206a-4e8a-abfe-774b780e91c3	8
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	28b4e26e-206a-4e8a-abfe-774b780e91c3	8
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	28b4e26e-206a-4e8a-abfe-774b780e91c3	8
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	d59098da-1395-49fb-9fd6-947bbbeed56f	7
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	d59098da-1395-49fb-9fd6-947bbbeed56f	7
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	d59098da-1395-49fb-9fd6-947bbbeed56f	7
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	d59098da-1395-49fb-9fd6-947bbbeed56f	7
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	cc3516cd-985c-489f-b4a1-8477876c5a97	6
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	cc3516cd-985c-489f-b4a1-8477876c5a97	6
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	cc3516cd-985c-489f-b4a1-8477876c5a97	6
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	cc3516cd-985c-489f-b4a1-8477876c5a97	6
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	d8c251a6-d4da-4664-bff4-6868541d1178	1
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	1e1b762a-800f-b79c-e063-6294a90a99c9	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	d8c251a6-d4da-4664-bff4-6868541d1178	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	1e1b762a-800f-b79c-e063-6294a90a99c9	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	1e1b762a-800f-b79c-e063-6294a90a99c9	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	d8c251a6-d4da-4664-bff4-6868541d1178	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	1e1b762a-800f-b79c-e063-6294a90a99c9	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	d8c251a6-d4da-4664-bff4-6868541d1178	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0868-40	00121086840	4 TRAY in 1 CASE (0121-0868-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)	4 tray	2020-07-17	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]	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	9
Nystatin Oral Suspension USP [100,000 units per mL]	Cardinal Health 107, LLC	2026-02-26	HUMAN PRESCRIPTION DRUG LABEL	7
Nystatin Oral Suspension USP [100,000 units per mL]	RedPharm Drug	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Nystatin Oral Suspension USP [100,000 units per mL] I0868C0124 R01/24	American Health Packaging	2024-02-22	HUMAN PRESCRIPTION DRUG LABEL	1
Nystatin Oral Suspension USP [100,000 units per mL]	A-S Medication Solutions	2023-10-19	HUMAN PRESCRIPTION DRUG LABEL	6