Nystatin

Product NDC: 63629-2598
11-digit product format: 636292598
Labeler code: 63629
Product ID: 63629-2598_3810a365-4f0f-4b39-9219-89ff274534f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA062512
Marketing category: ANDA
Marketing start: 1995-04-15
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 [USP'U]/mL
Pharmacologic classes: Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-2598		D	Discontinued by firm		2026-07-31
excluded package	package	63629-2598	63629-2598-1	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
A062512-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062512-001	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	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`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	A062512-001	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 Oral Suspension	NYSTATIN	Xttrium Laboratories, Inc.	4a670371-d373-1ba6-e063-6394a90a13b6	2026-02-06	Adverse reactions	Exact identifier application applno (ANDA): 062512 application number: ANDA062512
Nystatin	NYSTATIN	A-S Medication Solutions	e069d495-7f1a-4970-8f4d-aa93d124b3fc	2023-02-04	Adverse reactions	Exact identifier application applno (ANDA): 062512 application number: ANDA062512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2598-1	ML - Milliliter	63629-2598	b32104ac-e3fe-401b-8b6e-caa04c0c1c44	1	2013-05-02