Home NDC 69306-111-60 Dexamethasone
Product NDC 69306-111
Requested package NDC 69306-111-60
11-digit product format 693060111
Labeler code 69306
Product ID 69306-111_c479d9ec-ec8d-7228-e053-2a95a90a9644
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form TABLET
Route ORAL
Labeler Doc Rx
Application ANDA088306
Marketing category ANDA
Marketing start 1983-09-15
Substance DEXAMETHASONE
Active strength 1 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog .
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 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP 1983-09-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RS 1983-09-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP 1983-09-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP 1983-09-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP 1983-09-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP 1983-09-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP 1983-09-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP 1983-09-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP 1983-09-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL AB RLD, RS 1983-09-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088306-001 DEXAMETHASONE 1MG TABLET / ORAL BP RLD, RS 1983-09-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dexamethasone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXAMETHASONE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7S5I7G3JQL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197579 Internal RxNorm lookup 197581 Internal RxNorm lookup 197582 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 69306-111-60 Dexamethasone 60 in 1 BOTTLE, PLASTIC TABLET 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69306-111 DEXAMETHASONE TABLET [DOC RX] 4 Current NDC, Legacy NDC, 1 package rows 20210613_f1c30431-554b-4161-9d8c-5795c689e0bd.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 · 2 matching rows.
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 69306-111-60 69306011160 60 TABLET in 1 BOTTLE, PLASTIC (69306-111-60) 60 tablet 2020-06-25 0000-00-00 No No Current