Home NDC 21695-185 Nystatin and Triamcinolone
Product NDC 21695-185
11-digit product format 216950185
Labeler code 21695
Product ID 21695-185_9b245d7c-00c0-472e-b213-13fbe9973ee1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin and Triamcinolone Acetonide
Dosage form CREAM
Route TOPICAL
Labeler Rebel Distributors Corp
Application ANDA062364
Marketing category ANDA
Marketing start 1987-12-22
Marketing end 0000-00-00
Substance NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength 100000 [USP'U]/g; mg/g
Pharmacologic classes Polyene Antifungal [EPC],Polyenes [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062364-001 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.
Product history page 1 of 2 · 44 observed 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 2026-10-15 13:18:30 2026-09 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A062364-001 AT 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062364-001 AT 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062364-001 AT 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A062364-001 AT 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21695-185-15 Nystatin and Triamcinolone 15 g in 1 TUBE CREAM 15 1 21695-185-30 Nystatin and Triamcinolone 30 g in 1 TUBE CREAM 30 1 21695-185-60 Nystatin and Triamcinolone 60 g in 1 TUBE CREAM 60 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-185 NYSTATIN AND TRIAMCINOLONE (NYSTATIN AND TRIAMCINOLONE ACETONIDE) CREAM [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 3 package rows 20111118_9b245d7c-00c0-472e-b213-13fbe9973ee1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 21695-185-15 21695018515 15 g in 1 TUBE 15 g Historical 21695-185-30 21695018530 30 g in 1 TUBE 30 g Historical 21695-185-60 21695018560 60 g in 1 TUBE 60 g Historical