HYDROCORTISONE
- Product NDC
- 0115-1696
- 11-digit product format
- 001151696
- Labeler code
- 0115
- Product ID
- 0115-1696_f28149c1-c377-40ad-9d87-2f909eacf9e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA040646
- Marketing category
- ANDA
- Marketing start
- 2007-03-30
- Substance
- HYDROCORTISONE
- Active strength
- 5 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 |
|---|---|---|---|---|---|---|---|
| A040646-001 | HYDROCORTISONE | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | |
| A040646-002 | HYDROCORTISONE | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | |
| A040646-003 | HYDROCORTISONE | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040646-001 | AB |
| A040646-002 | AB |
| A040646-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040646-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2007-03-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040646-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2007-03-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040646-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2007-03-30 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040646-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040646-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040646-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040646-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040646-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040646-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040646-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040646-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040646-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040646-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040646-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040646-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040646-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040646-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040646-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040646-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040646-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040646-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040646-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040646-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040646-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040646-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040646-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040646-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040646-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040646-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040646-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040646-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040646-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040646-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040646-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040646-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040646-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040646-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040646-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040646-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040646-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040646-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040646-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040646-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDROCORTISONE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WI4X0X7BPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9fe627ad-4aba-4bd1-8590-6cc2d61674ba | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0115-1696-06 | 2023-02-03 | C162847 | 48780-1 | f386c649-b296-0266-e053-dadaa90a7c1a | Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg Rx only |
| 0115-1696-06 | 2023-01-30 | C162847 | 48780-1 | f386c649-b296-0266-e053-dadaa90a7c1a | Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0115-1696-06 | HYDROCORTISONE | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0115-1696-06 | EA - Each | 0115-1696 | ff270cf6-a285-4a21-b3ce-08e373db9ba2 | 1 | 2017-04-05 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| HYDROCORTISONE | HYDROCORTISONE | Preferred Pharmaceuticals Inc. | 0bbb8a63-ae1d-41d7-b201-d1b171b31f46 | 2026-05-11 | Warnings, Adverse reactions | 040646 ANDA040646 |
| HYDROCORTISONE | HYDROCORTISONE | Major Pharmaceuticals | 91885fc8-876f-4a4d-8ae5-eb246a335808 | 2025-09-10 | Warnings, Adverse reactions | 040646 ANDA040646 |
| HYDROCORTISONE | HYDROCORTISONE | AvPAK | f3956208-291c-7374-e053-2a95a90a4628 | 2025-01-09 | Warnings, Adverse reactions | 040646 ANDA040646 |
| HYDROCORTISONE | HYDROCORTISONE | Bryant Ranch Prepack | 47bfae62-bf25-413e-93fc-3c72c901f1a5 | 2024-07-18 | Warnings, Adverse reactions | 040646 ANDA040646 |
| HYDROCORTISONE | HYDROCORTISONE | Bryant Ranch Prepack | 6c676166-2471-478c-b662-f8c9c168977b | 2024-07-17 | Warnings, Adverse reactions | 040646 ANDA040646 |
| HYDROCORTISONE | HYDROCORTISONE | Bryant Ranch Prepack | 134fae59-f928-4304-86ca-2271b593caf4 | 2024-07-15 | Warnings, Adverse reactions | 040646 ANDA040646 |
| HYDROCORTISONE | HYDROCORTISONE | Amneal Pharmaceuticals of New York LLC | 9fe627ad-4aba-4bd1-8590-6cc2d61674ba | 2024-07-03 | Warnings, Adverse reactions | 040646 ANDA040646 0115-1696 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0115-1696-06 | 00115169606 | 50 TABLET in 1 BOTTLE, PLASTIC (0115-1696-06) | 50 tablet | 2007-03-30 | 0000-00-00 | No | No | Current |