Nystop

Product NDC: 72162-1124
11-digit product format: 721621124
Labeler code: 72162
Product ID: 72162-1124_2d351e4f-1d0b-4021-a2b4-b2dd3243702a
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.

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	A064118-001	NYSTOP	100,000 UNITS/GM	POWDER / TOPICAL	AT		1996-08-16	`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	A064118-001	AT	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
Nystop	NYSTATIN	Bryant Ranch Prepack	0bb31239-fb77-442a-a9ee-ba61b45e7e68	2026-07-14	Adverse reactions	Exact identifier application applno (ANDA): 064118 application number: ANDA064118 ndc (product): 72162-1124
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
Nystop	NYSTATIN	Bryant Ranch Prepack	5bce98a3-2964-4edc-b8da-8a46dafadf5e	2024-01-11	Adverse reactions	Exact identifier application applno (ANDA): 064118 application number: ANDA064118

Additional Listing Data#

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

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
0bb31239-fb77-442a-a9ee-ba61b45e7e68	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	SPL version
72162-1124-2	Nystop	15 g in 1 BOTTLE, PLASTIC	POWDER	15	102
72162-1124-3	Nystop	30 g in 1 BOTTLE, PLASTIC	POWDER	30	102
72162-1124-6	Nystop	60 g in 1 BOTTLE, PLASTIC	POWDER	60	102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1124-2	GM - Gram	72162-1124	6c2e216e-b95a-4c12-9b3f-95d5f54d633e	1	2025-02-10
72162-1124-3	GM - Gram	72162-1124	5766d1d7-9f4b-4b87-96e3-cc5f211ac88b	1	2025-05-14
72162-1124-6	GM - Gram	72162-1124	2f4f50eb-3284-4051-96eb-98c60dee25c4	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1124	NYSTOP (NYSTATIN) POWDER [BRYANT RANCH PREPACK]	101	Current NDC, 3 package rows	20250406_0bb31239-fb77-442a-a9ee-ba61b45e7e68.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
646456	nystatin 100,000 UNT/GM Topical Powder	PSN	0bb31239-fb77-442a-a9ee-ba61b45e7e68	102
261178	NYSTOP 100,000 UNT/GM Topical Powder	PSN	0bb31239-fb77-442a-a9ee-ba61b45e7e68	102
261178	nystatin 100 UNT/MG Topical Powder [Nystop]	SBD	0bb31239-fb77-442a-a9ee-ba61b45e7e68	102
646456	nystatin 100 UNT/MG Topical Powder	SCD	0bb31239-fb77-442a-a9ee-ba61b45e7e68	102
646456	nystatin 100,000 UNT/GM Topical Powder	SY	0bb31239-fb77-442a-a9ee-ba61b45e7e68	102
261178	Nystop 100 UNT/MG Topical Powder	SY	0bb31239-fb77-442a-a9ee-ba61b45e7e68	102
261178	Nystop 100,000 UNT/GM Topical Powder	SY	0bb31239-fb77-442a-a9ee-ba61b45e7e68	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1124-2	72162112402	15 g in 1 BOTTLE, PLASTIC (72162-1124-2)	15 g	2024-12-24	No	No	Current
72162-1124-3	72162112403	30 g in 1 BOTTLE, PLASTIC (72162-1124-3)	30 g	2024-12-24	No	No	Current
72162-1124-6	72162112406	60 g in 1 BOTTLE, PLASTIC (72162-1124-6)	60 g	2024-12-24	No	No	Current