Dexamethasone
- Product NDC
- 0054-4180
- 11-digit product format
- 000544180
- Labeler code
- 0054
- Product ID
- 0054-4180_286734bc-8329-4f44-a20b-610cf7b67591
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA, Inc.
- Application
- ANDA084612
- Marketing category
- ANDA
- Marketing start
- 1975-06-03
- Substance
- DEXAMETHASONE
- Active strength
- .75 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
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2022-04-08 23:34 UTC | 2022-04 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | BP | Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | Approved before 1982 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | BP | Approved before 1982 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | BP | Approved before 1982 | 5aa47cf7b7d7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2022-04-08 23:34 UTC | 2022-04 | A084612-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A084612-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A084612-001 | BP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A084612-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A084612-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A084612-001 | BP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A084612-001 | BP | 1 | 5aa47cf7b7d7… |
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 0054-4180 |
| 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 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexamethasone
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXAMETHASONE | .75 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7S5I7G3JQL | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 197577 | Internal RxNorm lookup |
| 197579 | Internal RxNorm lookup |
| 197580 | Internal RxNorm lookup |
| 197581 | Internal RxNorm lookup |
| 197582 | Internal RxNorm lookup |
| 197583 | Internal RxNorm lookup |
| 309684 | Internal RxNorm lookup |
| 309686 | Internal RxNorm lookup |
| 343033 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b15200fb-1826-472b-a907-e677a272513b | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0054-4180-25 | Dexamethasone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 11 | |
| 0054-4180-25 | Dexamethasone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0054-4180-25 | EA - Each | 0054-4180 | 1812bbfb-41c1-4708-a1fa-1e1c1342d685 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0054-4180 | DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [HIKMA PHARMACEUTICALS USA, INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20240308_b15200fb-1826-472b-a907-e677a272513b.zip |
| 0054-4180 | DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION [ROXANE LABORATORIES, INC.] | 8 | Current NDC, Legacy NDC | 20071101_537B424A-3E07-4C81-978C-1AD99014032A.zip |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0054-4180-25 | 00054418025 | 100 TABLET in 1 BOTTLE, PLASTIC (0054-4180-25) | 100 tablet | 1975-06-03 | 0000-00-00 | No | No | Current |