FDA.reportPublic FDA data

Nystatin

Product NDC
0121-0810
11-digit product format
001210810
Labeler code
0121
Product ID
0121-0810_d57cde69-0eb9-180d-e053-2995a90a33aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA203621
Marketing category
ANDA
Marketing start
2016-02-01
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui312055

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0810-02Nystatin60 mL in 1 BOTTLE, DROPPERSUSPENSION609
0121-0810-16Nystatin473 mL in 1 BOTTLESUSPENSION4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0810-02ML - Milliliter0121-081074585cc8-9e6f-4d89-9243-28d79ee1f4ee12016-09-02
0121-0810-16ML - Milliliter0121-0810589842bf-fdae-4623-802f-571932da0a8012016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0810NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]9Current NDC, Legacy NDC, 2 package rows20220114_31e3da10-5a7b-4bc5-8a4f-3e786b64c13a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN31e3da10-5a7b-4bc5-8a4f-3e786b64c13a9
312055nystatin 100000 UNT/ML Oral SuspensionSCD31e3da10-5a7b-4bc5-8a4f-3e786b64c13a9
312055nystatin 100,000 UNT/ML Oral SuspensionSY31e3da10-5a7b-4bc5-8a4f-3e786b64c13a9
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY31e3da10-5a7b-4bc5-8a4f-3e786b64c13a9
312055nystatin 100,000 UNT/mL Oral SuspensionPSN378c70ef-0fbc-4f0d-89c6-200735282fd73
312055nystatin 100000 UNT/ML Oral SuspensionSCD378c70ef-0fbc-4f0d-89c6-200735282fd73
312055nystatin 100,000 UNT/ML Oral SuspensionSY378c70ef-0fbc-4f0d-89c6-200735282fd73
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY378c70ef-0fbc-4f0d-89c6-200735282fd73
312055nystatin 100,000 UNT/mL Oral SuspensionPSN9233b813-01a2-4ce5-9a6d-26421882a7271
312055nystatin 100000 UNT/ML Oral SuspensionSCD9233b813-01a2-4ce5-9a6d-26421882a7271
312055nystatin 100,000 UNT/ML Oral SuspensionSY9233b813-01a2-4ce5-9a6d-26421882a7271
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY9233b813-01a2-4ce5-9a6d-26421882a7271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0810-020012108100260 mL in 1 BOTTLE, DROPPER (0121-0810-02) 60 ml2016-02-010000-00-00NoNoCurrent
0121-0810-1600121081016473 mL in 1 BOTTLE (0121-0810-16) 473 ml2016-02-010000-00-00NoNoCurrent