Hydrocortisone
- Product NDC
- 64380-970
- Requested package NDC
- 64380-970-25
- 11-digit product format
- 643800970
- Labeler code
- 64380
- Product ID
- 64380-970_e31ab65b-eef6-4d60-98fe-e2150a130b9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA207029
- Marketing category
- ANDA
- Marketing start
- 2020-09-25
- Substance
- HYDROCORTISONE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207029-001 | HYDROCORTISONE | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | |
| A207029-002 | HYDROCORTISONE | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | |
| A207029-003 | HYDROCORTISONE | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207029-001 | AB |
| A207029-002 | AB |
| A207029-003 | 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 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207029-002 | HYDROCORTISONE | 10MG | TABLET / ORAL | AB | 2017-04-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207029-003 | HYDROCORTISONE | 20MG | TABLET / ORAL | AB | 2017-04-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207029-001 | HYDROCORTISONE | 5MG | TABLET / ORAL | AB | 2017-04-27 | 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 | A207029-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207029-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207029-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207029-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207029-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207029-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207029-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207029-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207029-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207029-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207029-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207029-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207029-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207029-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207029-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207029-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207029-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207029-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207029-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207029-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207029-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207029-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207029-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207029-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207029-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207029-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207029-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207029-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207029-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207029-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207029-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207029-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207029-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207029-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207029-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207029-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207029-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207029-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207029-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207029-001 | AB | 1 | 8072bd15b7f6… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydrocortisone | HYDROCORTISONE | Strides Pharma Science Limited | 90a46849-5b75-467b-9bc5-8f192d4d20d2 | 2026-03-11 | Warnings, Adverse reactions | 207029 ANDA207029 64380-970-25 64380-970 64380097025 |
| Hydrocortisone | HYDROCORTISONE | PD-Rx Pharmaceuticals, Inc. | 931ed426-89a1-4877-a4a5-cb963d51e717 | 2026-02-25 | Warnings, Adverse reactions | 207029 ANDA207029 |
| Hydrocortisone | HYDROCORTISONE | Strides Pharma Inc. | c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6 | 2026-01-08 | Warnings, Adverse reactions | 207029 ANDA207029 |
| Hydrocortisone | HYDROCORTISONE | Chartwell RX, LLC. | 4b6edbc4-7afb-4fb5-a16e-66ce70916f09 | 2025-12-10 | Warnings, Adverse reactions | 207029 ANDA207029 |
| Hydrocortisone | HYDROCORTISONE | American Health Packaging | 506aab0d-9308-4d60-90b3-7d64952fff36 | 2025-05-25 | Warnings, Adverse reactions | 207029 ANDA207029 |
| Hydrocortisone | HYDROCORTISONE | Asclemed USA, Inc. | b8437441-a4a6-4fb5-82eb-e49af69704f4 | 2021-04-10 | Warnings, Adverse reactions | 207029 ANDA207029 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocortisone
- Listing expiration
- 2027-12-31
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 |
|---|---|
| 90a46849-5b75-467b-9bc5-8f192d4d20d2 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64380-970-25 | 2024-02-13 | C162847 | 48780-1 | 1030e365-4c67-111a-e063-dadaa90a10e2 | Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg |
| 64380-970-25 | 2024-02-13 | C162847 | 48780-1 | 1030e365-4c67-111a-e063-dadaa90a10e2 | Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg |
| 64380-970-25 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4c67-111a-e063-dadaa90a10e2 | Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg |
| 64380-970-25 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4c67-111a-e063-dadaa90a10e2 | Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64380-970-25 | Hydrocortisone | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64380-970-25 | 64380097025 | 50 TABLET in 1 BOTTLE, PLASTIC (64380-970-25) | 50 tablet | 2020-09-25 | 0000-00-00 | No | No | Current |