Nystatin

Product NDC: 0093-0983
11-digit product format: 000930983
Labeler code: 0093
Product ID: 0093-0983_b55205c3-f0be-44eb-a267-3af07c1639f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA062506
Marketing category: ANDA
Marketing start: 1990-09-30
Substance: NYSTATIN
Active strength: 500000 [USP'U]/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	0093-0983		UNFINISHED	Active or certified unfinished drug listing		2026-07-31
unfinished package	package	0093-0983	0093-0983-99	UNFINISHED	Active or certified unfinished drug listing		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
A062506-001	NYSTATIN	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062506-001	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	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`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	A062506-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	AvKARE	8fd35f97-5405-2160-ca0f-35034ecd5a92	2025-09-18	Adverse reactions	Exact identifier application applno (ANDA): 062506 application number: ANDA062506
Nystatin	NYSTATIN	Teva Pharmaceuticals USA, Inc.	f03b294d-10cd-4bba-92c8-42ae9b110cd0	2022-11-01	Adverse reactions	Exact identifier application applno (ANDA): 062506 application number: ANDA062506 ndc (product): 0093-0983

Additional Listing Data#

Finished product: Yes
Brand name base: Nystatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NYSTATIN	500000 [USP'U]/1

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
312059	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
f03b294d-10cd-4bba-92c8-42ae9b110cd0	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0093-0983-01	2024-02-06	C162847	48780-1	1030e365-1144-111a-e063-dadaa90a10e2	Nystatin Tablets, USP Rx only
0093-0983-01	2024-01-30	C162847	48780-1	1030e365-1144-111a-e063-dadaa90a10e2	Nystatin Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-0983-01	Nystatin	100 in 1 BOTTLE	TABLET, FILM COATED	100		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0983-01	EA - Each	0093-0983	a85e584d-5dd6-4f15-b3c0-733ec7d4b504	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NYSTATIN	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
NYSTATIN	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
NYSTATIN	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
NYSTATIN	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
NYSTATIN	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.]	1
NYSTATIN	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.]	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0983	NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20240207_f03b294d-10cd-4bba-92c8-42ae9b110cd0.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
312059	nystatin 500,000 UNT Oral Tablet	PSN	f03b294d-10cd-4bba-92c8-42ae9b110cd0	12
312059	nystatin 500000 UNT Oral Tablet	SCD	f03b294d-10cd-4bba-92c8-42ae9b110cd0	12
312059	nystatin 500,000 UNT Oral Tablet	SY	f03b294d-10cd-4bba-92c8-42ae9b110cd0	12
312059	nystatin 500,000 UNT Oral Tablet	PSN	8fd35f97-5405-2160-ca0f-35034ecd5a92	7
312059	nystatin 500000 UNT Oral Tablet	SCD	8fd35f97-5405-2160-ca0f-35034ecd5a92	7
312059	nystatin 500,000 UNT Oral Tablet	SY	8fd35f97-5405-2160-ca0f-35034ecd5a92	7
312059	nystatin 500,000 UNT Oral Tablet	PSN	fc0cc939-3ad1-47f2-87b9-cdd91712e0db	3
312059	nystatin 500000 UNT Oral Tablet	SCD	fc0cc939-3ad1-47f2-87b9-cdd91712e0db	3
312059	nystatin 500,000 UNT Oral Tablet	SY	fc0cc939-3ad1-47f2-87b9-cdd91712e0db	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-0983-01	00093098301	100 TABLET, FILM COATED in 1 BOTTLE (0093-0983-01)	1990-09-30	0000-00-00	No	No	Current
0093-0983-99	00093098399	681818 TABLET, FILM COATED in 1 PAIL (0093-0983-99)	23-JUN-23				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin Tablets USP Rx only	AvKARE	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	7
Nystatin Tablets, USP Rx only	Teva Pharmaceuticals USA, Inc.	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	12
NYSTATIN TABLETS USP 0983 Rx only	Carilion Materials Management	2013-10-15	HUMAN PRESCRIPTION DRUG LABEL	3