Home NDC 0713-0678 Nystatin
Product NDC 0713-0678
11-digit product format 007130678
Labeler code 0713
Product ID 0713-0678_ee0cb97f-1642-0dc0-e053-2995a90a8db3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin Cream
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA061966
Marketing category ANDA
Marketing start 2015-04-01
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 A061966-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A061966-001 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 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 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 A061966-001 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 0713-0678-15 Nystatin 1 in 1 CARTON CREAM 1 7 0713-0678-15 Nystatin 15 g in 1 TUBE CREAM 15 7 0713-0678-31 Nystatin 30 g in 1 TUBE CREAM 30 7 0713-0678-31 Nystatin 1 in 1 CARTON CREAM 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Algeldrate INACTIVE INGREDIENT 03J11K103C NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Ceteareth-15 INACTIVE INGREDIENT 867H4YOZ8Z NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Sorbitol INACTIVE INGREDIENT 506T60A25R NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0678 NYSTATIN (NYSTATIN CREAM) CREAM [COSETTE PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 4 package rows 20221123_ec1b52af-d38e-eba1-e63c-dba4341d3af2.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 a1b5ccb2-d0d6-46cc-b792-6920b50d0a03 10 543546 nystatin 100000 UNT/ML Topical Cream SCD a1b5ccb2-d0d6-46cc-b792-6920b50d0a03 10 543546 nystatin 100,000 UNT/GM Topical Cream SY a1b5ccb2-d0d6-46cc-b792-6920b50d0a03 10 543546 nystatin 100,000 UNT/GM Topical Cream PSN ec1b52af-d38e-eba1-e63c-dba4341d3af2 7 543546 nystatin 100000 UNT/ML Topical Cream SCD ec1b52af-d38e-eba1-e63c-dba4341d3af2 7 543546 nystatin 100,000 UNT/GM Topical Cream SY ec1b52af-d38e-eba1-e63c-dba4341d3af2 7 543546 nystatin 100,000 UNT/GM Topical Cream PSN 92ab6d9a-f639-226a-e053-2a95a90a731f 1 543546 nystatin 100,000 UNT/GM Topical Cream PSN 42f21220-c68a-d748-e063-6394a90a1e2f 1 543546 nystatin 100,000 UNT/GM Topical Cream PSN da44d87a-159e-24d4-e053-2a95a90a09d9 1 543546 nystatin 100,000 UNT/GM Topical Cream PSN b1efcc2c-f71a-463d-9a02-fad7550f31ec 1 543546 nystatin 100,000 UNT/GM Topical Cream PSN 98bd8ccb-0c68-47b9-bcb4-c5d8217868d9 1 543546 nystatin 100000 UNT/ML Topical Cream SCD 42f21220-c68a-d748-e063-6394a90a1e2f 1 543546 nystatin 100000 UNT/ML Topical Cream SCD b1efcc2c-f71a-463d-9a02-fad7550f31ec 1 543546 nystatin 100000 UNT/ML Topical Cream SCD da44d87a-159e-24d4-e053-2a95a90a09d9 1 543546 nystatin 100000 UNT/ML Topical Cream SCD 98bd8ccb-0c68-47b9-bcb4-c5d8217868d9 1 543546 nystatin 100000 UNT/ML Topical Cream SCD 92ab6d9a-f639-226a-e053-2a95a90a731f 1 543546 nystatin 100,000 UNT/GM Topical Cream SY 42f21220-c68a-d748-e063-6394a90a1e2f 1 543546 nystatin 100,000 UNT/GM Topical Cream SY b1efcc2c-f71a-463d-9a02-fad7550f31ec 1 543546 nystatin 100,000 UNT/GM Topical Cream SY 92ab6d9a-f639-226a-e053-2a95a90a731f 1 543546 nystatin 100,000 UNT/GM Topical Cream SY da44d87a-159e-24d4-e053-2a95a90a09d9 1 543546 nystatin 100,000 UNT/GM Topical Cream SY 98bd8ccb-0c68-47b9-bcb4-c5d8217868d9 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0713-0678-15 00713067815 1 TUBE in 1 CARTON (0713-0678-15) / 15 g in 1 TUBE 1 tube 2015-04-01 0000-00-00 No No Current 0713-0678-31 00713067831 1 TUBE in 1 CARTON (0713-0678-31) / 30 g in 1 TUBE 1 tube 2015-04-01 0000-00-00 No No Current