FDA.reportPublic FDA data

Nystatin

Product NDC
0904-7276
11-digit product format
009047276
Labeler code
0904
Product ID
0904-7276_764e2a6a-00ef-4340-8810-9537bae3b0be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Major Pharmaceuticals
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
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
0904-7276-41Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION57
0904-7276-70Nystatin10 in 1 CASESUSPENSION107
0904-7276-70Nystatin10 in 1 TRAYSUSPENSION107
0904-7276-92Nystatin5 in 1 CASESUSPENSION57
0904-7276-92Nystatin10 in 1 TRAYSUSPENSION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7276-41ML - Milliliter0904-727696e2ec22-526d-48c6-88ae-1ae44083a2af12022-12-07
0904-7276-70ML - Milliliter0904-727610302933-43ab-48c8-a467-039534481bd112022-12-07
0904-7276-92ML - Milliliter0904-72762a070892-5792-41ba-aff7-624e85e3245b12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7276NYSTATIN SUSPENSION [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 5 package rows20250305_17b9e33d-da9c-467a-bbc4-9e257727f19a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN17b9e33d-da9c-467a-bbc4-9e257727f19a7
312055nystatin 100000 UNT/ML Oral SuspensionSCD17b9e33d-da9c-467a-bbc4-9e257727f19a7
312055nystatin 100,000 UNT/ML Oral SuspensionSY17b9e33d-da9c-467a-bbc4-9e257727f19a7
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY17b9e33d-da9c-467a-bbc4-9e257727f19a7
312055nystatin 100,000 UNT/mL Oral SuspensionPSN56aca0e2-8691-4701-beba-e2315524709f4
312055nystatin 100000 UNT/ML Oral SuspensionSCD56aca0e2-8691-4701-beba-e2315524709f4
312055nystatin 100,000 UNT/ML Oral SuspensionSY56aca0e2-8691-4701-beba-e2315524709f4
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY56aca0e2-8691-4701-beba-e2315524709f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7276-41009047276415 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0904-7276-700090472767010 TRAY in 1 CASE (0904-7276-70) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7276-41) 10 tray2022-11-280000-00-00NoNoCurrent
0904-7276-92009047276925 TRAY in 1 CASE (0904-7276-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7276-41) 5 tray2022-11-280000-00-00NoNoCurrent