Home NDC 70000-0204-1 Leader Nasal Allergy
Product NDC 70000-0204
Requested package NDC 70000-0204-1
11-digit product format 700000204
Labeler code 70000
Product ID 70000-0204_c8578c47-a9e5-47db-822e-a906e2f80f1f
Type HUMAN OTC DRUG
Nonproprietary name Triamcinolone acetonide
Dosage form SPRAY, METERED
Route NASAL
Labeler Cardinal Health 110, LLC. dba Leader
Application ANDA078104
Marketing category ANDA
Marketing start 2016-12-15
Marketing end 0000-00-00
Substance TRIAMCINOLONE ACETONIDE
Active strength 55 ug/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078104-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 A078104-002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0204 LEADER NASAL ALLERGY (TRIAMCINOLONE ACETONIDE) SPRAY, METERED [CARDINAL HEALTH 110, LLC. DBA LEADER] 6 Legacy NDC 20221115_d4f3a3c9-f0ab-4b6b-93cc-d6fc47d07cab.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 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0204-1 70000020401 1 BOTTLE in 1 CARTON (70000-0204-1) > 120 SPRAY, METERED in 1 BOTTLE 1 bottle 2016-12-15 0000-00-00 No No Current