Home NDC 51672-4117-9 Nystatin
Product NDC 51672-4117
Requested package NDC 51672-4117-9
11-digit product format 516724117
Labeler code 51672
Product ID 51672-4117_29a58f9e-6262-8297-e063-6294a90ad86d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA062876
Marketing category ANDA
Marketing start 1988-02-29
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 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 A062876-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1988-02-29
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 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1988-02-29 a50c72e98297…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-4117-0 Nystatin 3785 mL in 1 BOTTLE SUSPENSION 3785 5 51672-4117-4 Nystatin 1 in 1 CARTON SUSPENSION 1 5 51672-4117-4 Nystatin 60 mL in 1 BOTTLE, DROPPER SUSPENSION 60 5 51672-4117-9 Nystatin 473 mL in 1 BOTTLE SUSPENSION 473 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 alcohol INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 benzaldehyde INACTIVE INGREDIENT TA269SD04T NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 edetate calcium disodium INACTIVE INGREDIENT 25IH6R4SGF NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sucrose INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 xanthan gum INACTIVE INGREDIENT TTV12P4NEE NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4117 NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 4 package rows 20241222_01c469b3-ec10-452c-8c02-3e7d22e40297.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4117-9 51672411709 473 mL in 1 BOTTLE (51672-4117-9) 473 ml 1988-02-29 0000-00-00 No No Current