Dexamethasone
- Product NDC
- 49999-059
- Requested package NDC
- 49999-059-06
- 11-digit product format
- 499990059
- Labeler code
- 49999
- Product ID
- 49999-059_519c3c22-9220-4d65-84a1-30bb24dbbcce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA084612
- Marketing category
- ANDA
- Marketing start
- 1978-07-19
- Marketing end
- 0000-00-00
- Substance
- DEXAMETHASONE
- Active strength
- 4 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 package | package | 49999-059 | 49999-059-06 | D | Discontinued by firm | 2026-08-17 |
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 | 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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A084612-001 | DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A084612-002 | DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A084612-003 | DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A084612-004 | DEXAMETHASONE | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 |
| A084612-005 | DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A084612-006 | DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | |
| A084612-007 | DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A084612-001 | AB |
| A084612-002 | AB |
| A084612-003 | AB |
| A084612-004 | AB |
| A084612-005 | AB |
| A084612-006 | AB |
| A084612-007 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A084612-002 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A084612-003 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A084612-004 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-005 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A084612-006 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A084612-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-002 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-003 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-004 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-005 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-006 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-002 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-003 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-004 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-005 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-006 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-002 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-003 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-004 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-005 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-006 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5c6f7cd8ea54… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A084612-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-007 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A084612-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A084612-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A084612-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A084612-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A084612-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A084612-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A084612-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A084612-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A084612-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A084612-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A084612-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A084612-001 | AB | 1 | 5c6f7cd8ea54… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49999-059-06 | EA - Each | 49999-059 | d71866a7-9edb-4584-b4e9-1f7cd64b0a08 | 1 | 2012-07-24 |
| 49999-059-12 | EA - Each | 49999-059 | f98c18c8-7eb2-41d4-a5ba-e65a372b5166 | 1 | 2018-12-13 |
| 49999-059-30 | EA - Each | 49999-059 | bdba4537-5969-4ca6-abc0-8e9d23c7d909 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 | REMEDYREPACK INC. | f5c9b70b-b835-4f3b-9643-0aec50a0d3f2 | 2026-07-07 | Warnings, Adverse reactions | 084612 ANDA084612 |
| Dexamethasone | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | 89e1d458-7caa-430f-9c54-360889899a73 | 2026-06-12 | Warnings, Adverse reactions | 084612 ANDA084612 |
| Dexamethasone | DEXAMETHASONE | Cardinal Health 107, LLC | bf8acfdb-8dc8-4a69-90b0-33c680c421d6 | 2026-05-15 | Warnings, Adverse reactions | 084612 ANDA084612 |
| Dexamethasone | DEXAMETHASONE | Northwind Health Company, LLC | aa30086a-8551-413e-9cf2-6393093cfcfd | 2025-12-26 | Warnings, Adverse reactions | 084612 ANDA084612 |
| Dexamethasone | DEXAMETHASONE | Golden State Medical Supply, Inc. | a7455c92-41ce-4e87-e053-2995a90a610f | 2025-12-11 | Warnings, Adverse reactions | 084612 ANDA084612 |
| Dexamethasone Intensol | DEXAMETHASONE INTENSOL | Hikma Pharmaceuticals USA, Inc. | b15200fb-1826-472b-a907-e677a272513b | 2025-06-06 | Warnings, Adverse reactions | 084612 ANDA084612 |
| DEXAMETHASONE | DEXAMETHASONE | Direct Rx | cc7140de-a205-f675-e053-2995a90ac22b | 2025-01-20 | Warnings, Adverse reactions | 084612 ANDA084612 |
| Dexamethasone | DEXAMETHASONE | Proficient Rx LP | 99296e80-3ca6-4430-9ef7-adca357c31b3 | 2022-06-01 | Warnings, Adverse reactions | 084612 ANDA084612 |
| Dexamethasone | DEXAMETHASONE | Doc Rx | f1c30431-554b-4161-9d8c-5795c689e0bd | 2021-06-11 | Warnings, Adverse reactions | 084612 ANDA084612 |
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | 89e570c9-3e64-433b-9779-b94332f2b5ef | 2020-02-25 | Warnings, Adverse reactions | 084612 ANDA084612 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49999-059-06 | 49999005906 | 6 TABLET in 1 BOTTLE, PLASTIC (49999-059-06) | 6 tablet | 1978-07-19 | 0000-00-00 | No | No | Current |