Home NDC 51672-1272-3 Nystatin and Triamcinolone Acetonide
Product NDC 51672-1272
Requested package NDC 51672-1272-3
11-digit product format 516721272
Labeler code 51672
Product ID 51672-1272_395e7f1c-ecc8-31cf-e063-6294a90aef62
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin and Triamcinolone Acetonide
Dosage form OINTMENT
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA063305
Marketing category ANDA
Marketing start 1993-03-29
Substance NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength 100000; 1 [USP'U]/g; mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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 A063305-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT / TOPICAL AT RS 1993-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A063305-001 AT
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 A063305-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT / TOPICAL AT RS 1993-03-29 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 A063305-001 AT 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nystatin and Triamcinolone Acetonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 [USP'U]/g TRIAMCINOLONE ACETONIDE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BDF1O1C72E Internal UNII lookup F446C597KA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1053697 Internal RxNorm lookup 1053753 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1272-1 Nystatin and Triamcinolone Acetonide 1 in 1 CARTON OINTMENT 1 6 51672-1272-1 Nystatin and Triamcinolone Acetonide 15 g in 1 TUBE OINTMENT 15 6 51672-1272-2 Nystatin and Triamcinolone Acetonide 1 in 1 CARTON OINTMENT 1 6 51672-1272-2 Nystatin and Triamcinolone Acetonide 30 g in 1 TUBE OINTMENT 30 6 51672-1272-3 Nystatin and Triamcinolone Acetonide 1 in 1 CARTON OINTMENT 1 6 51672-1272-3 Nystatin and Triamcinolone Acetonide 60 g in 1 TUBE OINTMENT 60 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Triamcinolone Acetonide ACTIVE INGREDIENT F446C597KA NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Triamcinolone Acetonide ACTIVE MOIETY F446C597KA NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 aluminum hydroxide INACTIVE INGREDIENT 5QB0T2IUN0 NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 mineral oil INACTIVE INGREDIENT T5L8T28FGP NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 petrolatum INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 sorbic acid INACTIVE INGREDIENT X045WJ989B NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Sorbitol INACTIVE INGREDIENT 506T60A25R NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN AND TRIAMCINOLONE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 TRIAMCINOLONE ACETONIDE ACTIVE INGREDIENT F446C597KA NYSTATIN AND TRIAMCINOLONE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN AND TRIAMCINOLONE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 TRIAMCINOLONE ACTIVE MOIETY 1ZK20VI6TY NYSTATIN AND TRIAMCINOLONE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP NYSTATIN AND TRIAMCINOLONE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN AND TRIAMCINOLONE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1272 NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 6 package rows 20241222_2fd97fc5-cae5-43dd-a3c7-c9a03876153e.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 51672-1272-3 51672127203 1 TUBE in 1 CARTON (51672-1272-3) / 60 g in 1 TUBE 1 tube 1993-03-29 0000-00-00 No No Current