Dexamethasone
- Product NDC
- 67296-1413
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 67296-1413 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 67296-1413 | 67296-1413-1 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 67296-1413 | 67296-1413-2 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 67296-1413 | 67296-1413-4 | I | Inactivated by FDA | 2026-08-03 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 67296-1413-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 67296-1413-4 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 67296-1413-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 67296-1413-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 67296-1413-4 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 67296-1413-2 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 67296-1413-1 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 67296-1413-4 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 67296-1413-2 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 67296-1413-1 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 67296-1413-4 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 67296-1413-2 | 1332a3947898… | d4bfe170f9cd… |
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 | 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#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088316-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088316-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088316-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088316-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088316-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088316-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088316-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088316-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088316-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088316-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088316-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088316-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088316-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088316-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088316-001 | BP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A088316-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088316-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088316-001 | BP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A088316-001 | BP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A088316-001 | BP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088316-001 | BP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A088316-001 | BP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A088316-001 | BP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088316-001 | BP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088316-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088316-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088316-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088316-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088316-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088316-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088316-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A088316-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A088316-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088316-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A088316-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A088316-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A088316-001 | AB | 1 | cb3db0bc1861… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1ea46721-9071-6b81-fd0a-a82bfbb014ec | Product name | 7 | 20250220 |
| 525701df-f985-480d-995a-e0ee70c2bdf4 | Product name | 5 | 20250128 |
| ea50b939-d92a-4100-84f5-1c1089663837 | Product name | 2 | 20240705 |
| 941f67d9-7f03-56d2-750c-36de24f654db | Product name | 3 | 20221117 |
| d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8 | Product name | 2 | 20220506 |
| 7b2c58e8-5850-4e3e-82e9-b1593b1de761 | Product name | 5 | 20220210 |
| 81e34474-b0a5-434f-8104-25d689efc99e | Product name | 1 | 20200303 |
| 05ab9c01-cd9a-4f59-b2e8-ddcb887cac39 | Product name | 1 | 20190408 |
| 0c7dba41-c919-5809-508d-4affe6cfcff2 | Product name | 2 | 20170817 |
| 399647c0-db89-02d1-991c-0c17b584482c | Product name | 1 | 20140508 |
| 3e9a6377-704f-dff7-b19f-56c98d40c444 | Product name | 1 | 20140508 |
| 4d2e6ff9-14f5-b84f-c39b-373b005712c1 | Product name | 1 | 20140508 |
| 725d71bf-f956-5cad-e556-fa39cb060dc8 | Product name | 1 | 20140508 |
| 9ea85abb-fa68-5da6-ab60-2c7eef579000 | Product name | 1 | 20140508 |
| d029211e-5e6b-725f-3696-ac6ff77da222 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 67296-1413-1 | 2026-01-29 | Dexamethasone Tablets 6MG |
| 67296-1413-2 | 2026-01-29 | Dexamethasone Tablets 6MG |
| 67296-1413-4 | 2026-01-29 | Dexamethasone Tablets 6MG |
| 67296-1413-1 | 2024-08-07 | Dexamethasone Tablets 6MG |
| 67296-1413-2 | 2024-08-07 | Dexamethasone Tablets 6MG |
| 67296-1413-4 | 2024-08-07 | Dexamethasone Tablets 6MG |
| 67296-1413-1 | 2023-01-30 | Dexamethasone Tablets 6MG |
| 67296-1413-2 | 2023-01-30 | Dexamethasone Tablets 6MG |
| 67296-1413-4 | 2023-01-30 | Dexamethasone Tablets 6MG |
DailyMed Package Descriptions#
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | a9fd2013-0797-4ec4-82c5-07d282522625 | 2020-09-17 | Warnings, Adverse reactions | 088316 ANDA088316 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197583 | dexAMETHasone 6 MG Oral Tablet | PSN | b95ba990-1f3e-5be1-e053-2995a90a6068 | 2 |
| 197583 | dexamethasone 6 MG Oral Tablet | SCD | b95ba990-1f3e-5be1-e053-2995a90a6068 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67296-1413-1 | 67296141301 | 10 TABLET in 1 BOTTLE (67296-1413-1) | 10 tablet | 2021-01-01 | 0000-00-00 | No | No | Current |
| 67296-1413-2 | 67296141302 | 2 TABLET in 1 BOTTLE (67296-1413-2) | 2 tablet | 2021-01-01 | 0000-00-00 | No | No | Current |
| 67296-1413-4 | 67296141304 | 4 TABLET in 1 BOTTLE (67296-1413-4) | 4 tablet | 2021-01-01 | 0000-00-00 | No | No | Current |