Home NDC 67296-1413-2 Dexamethasone
Product NDC 67296-1413
Requested package NDC 67296-1413-2
11-digit product format 672961413
Labeler code 67296
Product ID 67296-1413_b95bac1b-60e4-628a-e053-2a95a90a7d76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form TABLET
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA088316
Marketing category ANDA
Marketing start 2021-01-01
Marketing end 0000-00-00
Substance DEXAMETHASONE
Active strength 6 mg/1
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 4 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 2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL BP RS 1983-09-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RS 1983-09-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL BP RS 1983-09-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL BP RS 1983-09-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL BP RS 1983-09-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL BP RS 1983-09-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL BP RS 1983-09-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL BP RS 1983-09-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL BP RS 1983-09-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088316-001 DEXAMETHASONE 6MG TABLET / ORAL AB RLD, RS 1983-09-15 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 67296-1413-1 Dexamethasone 10 in 1 BOTTLE TABLET 10 2 67296-1413-2 Dexamethasone 2 in 1 BOTTLE TABLET 2 2 67296-1413-4 Dexamethasone 4 in 1 BOTTLE TABLET 4 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-1413 DEXAMETHASONE TABLET [REDPHARM DRUG, INC.] 2 Legacy NDC, 3 package rows 20240808_b95ba990-1f3e-5be1-e053-2995a90a6068.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 · 1 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 67296-1413-2 67296141302 2 TABLET in 1 BOTTLE (67296-1413-2) 2 tablet 2021-01-01 0000-00-00 No No Current