HOW SUPPLIED
Hydrocortisone Tablets USP, 10 mg are white to off-white, round shaped tablets, with score line on one side and debossed with ‘HC10’ on other side.
Bottles of 100: NDC 59651-414-01
Store at 20° to 25°C (68° to 77°F)
HOW SUPPLIED
- Manufacturer
- Northwestern Memorial HealthCare
- Effective date
- 2026-05-15
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-06-06 05:10:29
Label at a glance#
ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure2 sections
Label contents#
Full prescribing information#
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 87448150101 | Hydrocortisone Unit Dose Label.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59651-414-01 | EA - Each | 59651-414 | d27c313c-ee38-4e8d-bb43-ac6ab2eb87e1 | 1 | 2023-12-05 |
Products#
Every source-derived product name is available through these pages.
- Hydrocortisone
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87448-1501 | 87448-1501-1 |
| 59651-414 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214649-001 | HYDROCORTISONE | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | |
| A214649-002 | HYDROCORTISONE | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | |
| A214649-003 | HYDROCORTISONE | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214649-001 | AB |
| A214649-002 | AB |
| A214649-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214649-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2023-07-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214649-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2023-07-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214649-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2023-07-17 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214649-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214649-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214649-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A214649-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214649-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214649-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A214649-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214649-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214649-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214649-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214649-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214649-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214649-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214649-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214649-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214649-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214649-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214649-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214649-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214649-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214649-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214649-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214649-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214649-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214649-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214649-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214649-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214649-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214649-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214649-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214649-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214649-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214649-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A214649-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A214649-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A214649-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214649-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214649-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214649-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214649-001 | AB | 1 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| 51e0f7e0-cd47-87cc-e063-6394a90a4e8f | 51e0f7e0-cd46-87cc-e063-6394a90a4e8f | 2026-05-15 | 51e0f7e0-cd47-87cc-e063-6394a90a4e8f 51e0f7e0-cd46-87cc-e063-6394a90a4e8f | |||
| HYDROCORTISONE | HYDROCORTISONE | Aurobindo Pharma Limited | 6d820911-f50e-46a4-8174-c4ee89f6792e | 2024-06-13 | Warnings, Adverse reactions | 59651-414 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.