Home NDC 63629-2696-1 Dexamethasone
Product NDC 63629-2696
Requested package NDC 63629-2696-1
11-digit product format 636292696
Labeler code 63629
Product ID 63629-2696_67bddc0c-e88b-4b71-8068-4b62b7cf186f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form SOLUTION
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA088248
Marketing category ANDA
Marketing start 1983-09-01
Marketing end 0000-00-00
Substance DEXAMETHASONE
Active strength 1 mg/5mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A088248-001 DEXAMETHASONE DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RS 1983-09-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088248-001 DEXAMETHASONE 0.5MG/5ML SOLUTION / ORAL RLD, RS 1983-09-01 cb3db0bc1861…
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 · 1 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 63629-2696-1 63629269601 60 mL in 1 BOTTLE (63629-2696-1) 60 ml 2005-01-06 0000-00-00 No No Current