Home NDC 13668-534 Nystatin
Product NDC 13668-534
11-digit product format 136680534
Labeler code 13668
Product ID 13668-534_b5c975a5-4d7a-4177-b1e2-524bad92a5fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form OINTMENT
Route TOPICAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA211838
Marketing category ANDA
Marketing start 2019-01-29
Substance NYSTATIN
Active strength 100000 U/g
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A211838-001 NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2019-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211838-001 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 A211838-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2019-01-28 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 A211838-001 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 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 884308 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 13668-534-01 Nystatin 15 g in 1 TUBE OINTMENT 15 8 13668-534-02 Nystatin 30 g in 1 TUBE OINTMENT 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-534 NYSTATIN OINTMENT [TORRENT PHARMACEUTICALS LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20241208_4949dea7-d2b9-4e0d-974a-39408fa174ba.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 13668-534-01 13668053401 15 g in 1 TUBE (13668-534-01) 15 g 2019-01-29 0000-00-00 No No Current 13668-534-02 13668053402 30 g in 1 TUBE (13668-534-02) 30 g 2019-01-29 0000-00-00 No No Current