FDA.reportPublic FDA data

Nystatin

Product NDC
0121-0868
11-digit product format
001210868
Labeler code
0121
Product ID
0121-0868_15a142a2-4bb9-444e-8b22-73acf9f91f3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
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
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0868-00Nystatin10 in 1 CASESUSPENSION108
0121-0868-00Nystatin10 in 1 TRAYSUSPENSION108
0121-0868-02Nystatin60 mL in 1 BOTTLE, DROPPERSUSPENSION608
0121-0868-05Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION58
0121-0868-16Nystatin473 mL in 1 BOTTLESUSPENSION4738
0121-0868-40Nystatin4 in 1 CASESUSPENSION48
0121-0868-40Nystatin10 in 1 TRAYSUSPENSION108
0121-0868-50Nystatin10 in 1 TRAYSUSPENSION108
0121-0868-50Nystatin5 in 1 CASESUSPENSION58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0868-00ML - Milliliter0121-0868b068ec19-d240-4824-a64e-273e938ce59812020-08-06
0121-0868-02ML - Milliliter0121-08684ae76eca-a726-49f6-84c8-d8d6c9ee476512020-08-06
0121-0868-05ML - Milliliter0121-0868e2af12f7-3a29-4bd8-a874-d5e0c50d9a6712020-08-06
0121-0868-16ML - Milliliter0121-0868f3d006ad-0cdc-4f80-983f-3450ba73191b12020-08-06
0121-0868-40ML - Milliliter0121-0868831de8ef-a458-4bf3-94d7-fec8d021b6f412020-08-06
0121-0868-50ML - Milliliter0121-08682020f77a-6e92-4fc6-8c28-4e8675279aa312020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0868NYSTATIN SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]8Current NDC, Legacy NDC, 9 package rows20240906_28b4e26e-206a-4e8a-abfe-774b780e91c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN28b4e26e-206a-4e8a-abfe-774b780e91c38
312055nystatin 100000 UNT/ML Oral SuspensionSCD28b4e26e-206a-4e8a-abfe-774b780e91c38
312055nystatin 100,000 UNT/ML Oral SuspensionSY28b4e26e-206a-4e8a-abfe-774b780e91c38
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY28b4e26e-206a-4e8a-abfe-774b780e91c38
312055nystatin 100,000 UNT/mL Oral SuspensionPSNd59098da-1395-49fb-9fd6-947bbbeed56f7
312055nystatin 100000 UNT/ML Oral SuspensionSCDd59098da-1395-49fb-9fd6-947bbbeed56f7
312055nystatin 100,000 UNT/ML Oral SuspensionSYd59098da-1395-49fb-9fd6-947bbbeed56f7
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYd59098da-1395-49fb-9fd6-947bbbeed56f7
312055nystatin 100,000 UNT/mL Oral SuspensionPSNcc3516cd-985c-489f-b4a1-8477876c5a976
312055nystatin 100000 UNT/ML Oral SuspensionSCDcc3516cd-985c-489f-b4a1-8477876c5a976
312055nystatin 100,000 UNT/ML Oral SuspensionSYcc3516cd-985c-489f-b4a1-8477876c5a976
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYcc3516cd-985c-489f-b4a1-8477876c5a976
312055nystatin 100,000 UNT/mL Oral SuspensionPSNd8c251a6-d4da-4664-bff4-6868541d11781
312055nystatin 100,000 UNT/mL Oral SuspensionPSN1e1b762a-800f-b79c-e063-6294a90a99c91
312055nystatin 100000 UNT/ML Oral SuspensionSCDd8c251a6-d4da-4664-bff4-6868541d11781
312055nystatin 100000 UNT/ML Oral SuspensionSCD1e1b762a-800f-b79c-e063-6294a90a99c91
312055nystatin 100,000 UNT/ML Oral SuspensionSY1e1b762a-800f-b79c-e063-6294a90a99c91
312055nystatin 100,000 UNT/ML Oral SuspensionSYd8c251a6-d4da-4664-bff4-6868541d11781
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY1e1b762a-800f-b79c-e063-6294a90a99c91
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYd8c251a6-d4da-4664-bff4-6868541d11781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0868-000012108680010 TRAY in 1 CASE (0121-0868-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05) 10 tray2020-07-170000-00-00NoNoCurrent
0121-0868-020012108680260 mL in 1 BOTTLE, DROPPER (0121-0868-02) 60 ml2020-07-170000-00-00NoNoCurrent
0121-0868-05001210868055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-0868-1600121086816473 mL in 1 BOTTLE (0121-0868-16) 473 ml2020-07-170000-00-00NoNoCurrent
0121-0868-40001210868404 TRAY in 1 CASE (0121-0868-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05) 4 tray2020-07-170000-00-00NoNoCurrent
0121-0868-50001210868505 TRAY in 1 CASE (0121-0868-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05) 5 tray2020-07-170000-00-00NoNoCurrent