Home NDC 51672-1289 Nystatin
Product NDC 51672-1289
11-digit product format 516721289
Labeler code 51672
Product ID 51672-1289_3908cf94-b2b6-30a4-e063-6394a90add43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA064022
Marketing category ANDA
Marketing start 1993-01-28
Substance NYSTATIN
Active strength 100000 [USP'U]/g
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 A064022-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A064022-001 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 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 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 A064022-001 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 · 5 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nystatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BDF1O1C72E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 543546 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 51672-1289-1 Nystatin 15 g in 1 TUBE CREAM 15 6 51672-1289-1 Nystatin 1 in 1 CARTON CREAM 1 6 51672-1289-2 Nystatin 1 in 1 CARTON CREAM 1 6 51672-1289-2 Nystatin 30 g in 1 TUBE CREAM 30 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 algeldrate INACTIVE INGREDIENT 03J11K103C NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 ceteareth-15 INACTIVE INGREDIENT 867H4YOZ8Z NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 petrolatum INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 sorbitol INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 ALGELDRATE INACTIVE INGREDIENT 03J11K103C NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 ALGELDRATE INACTIVE INGREDIENT 03J11K103C NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 CETEARETH-12 INACTIVE INGREDIENT 7V4MR24V5P NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 CETEARETH-15 INACTIVE INGREDIENT 867H4YOZ8Z NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1289 NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 4 package rows 20230126_4d845b3f-ca26-4c47-b424-b6d783cc10e5.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 543546 nystatin 100,000 UNT/GM Topical Cream PSN 4d845b3f-ca26-4c47-b424-b6d783cc10e5 6 543546 nystatin 100000 UNT/ML Topical Cream SCD 4d845b3f-ca26-4c47-b424-b6d783cc10e5 6 543546 nystatin 100,000 UNT/GM Topical Cream SY 4d845b3f-ca26-4c47-b424-b6d783cc10e5 6 543546 nystatin 100,000 UNT/GM Topical Cream PSN 57825c04-dcb5-b76d-e053-2991aa0a4c1d 4 543546 nystatin 100,000 UNT/GM Topical Cream PSN cd387929-5b72-e3c0-e053-2a95a90adb22 4 543546 nystatin 100000 UNT/ML Topical Cream SCD 57825c04-dcb5-b76d-e053-2991aa0a4c1d 4 543546 nystatin 100000 UNT/ML Topical Cream SCD cd387929-5b72-e3c0-e053-2a95a90adb22 4 543546 nystatin 100,000 UNT/GM Topical Cream SY 57825c04-dcb5-b76d-e053-2991aa0a4c1d 4 543546 nystatin 100,000 UNT/GM Topical Cream SY cd387929-5b72-e3c0-e053-2a95a90adb22 4 543546 nystatin 100,000 UNT/GM Topical Cream PSN 5ef15e1c-66dc-4858-8552-d83e42c3883e 3 543546 nystatin 100,000 UNT/GM Topical Cream PSN cf6b7c68-7769-1808-e053-2995a90aa426 3 543546 nystatin 100000 UNT/ML Topical Cream SCD 5ef15e1c-66dc-4858-8552-d83e42c3883e 3 543546 nystatin 100000 UNT/ML Topical Cream SCD cf6b7c68-7769-1808-e053-2995a90aa426 3 543546 nystatin 100,000 UNT/GM Topical Cream SY cf6b7c68-7769-1808-e053-2995a90aa426 3 543546 nystatin 100,000 UNT/GM Topical Cream SY 5ef15e1c-66dc-4858-8552-d83e42c3883e 3 543546 nystatin 100,000 UNT/GM Topical Cream PSN bdb80797-20c8-4fbc-8ef8-b85d6aebdce5 1 543546 nystatin 100000 UNT/ML Topical Cream SCD bdb80797-20c8-4fbc-8ef8-b85d6aebdce5 1 543546 nystatin 100,000 UNT/GM Topical Cream SY bdb80797-20c8-4fbc-8ef8-b85d6aebdce5 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-1289-1 51672128901 1 TUBE in 1 CARTON (51672-1289-1) / 15 g in 1 TUBE 1 tube 1993-01-28 0000-00-00 No No Current 51672-1289-2 51672128902 1 TUBE in 1 CARTON (51672-1289-2) / 30 g in 1 TUBE 1 tube 1993-01-28 0000-00-00 No No Current