Hydrocortisone
- Product NDC
- 68071-4582
- 11-digit product format
- 680714582
- Labeler code
- 68071
- Product ID
- 68071-4582_bbf18e2d-9131-70a5-e053-2995a90abddd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA080706
- Marketing category
- ANDA
- Marketing start
- 2016-04-01
- Marketing end
- 0000-00-00
- Substance
- HYDROCORTISONE
- Active strength
- 25 mg/g
- 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#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68071-4582 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68071-4582 | 68071-4582-3 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | 68071-4582 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | ||
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-4582 | 68071-4582-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | 68071-4582 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | ||
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-4582 | 68071-4582-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | 68071-4582 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | ||
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-4582 | 68071-4582-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 68071-4582 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | ||
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-4582 | 68071-4582-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | 68071-4582 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | ||
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-4582 | 68071-4582-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 68071-4582 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | ||
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-4582 | 68071-4582-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | 68071-4582 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | ||
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68071-4582 | 68071-4582-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 68071-4582 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | ||
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68071-4582 | 68071-4582-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 68071-4582 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | ||
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68071-4582 | 68071-4582-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 68071-4582 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | ||
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68071-4582 | 68071-4582-3 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 68071-4582 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | ||
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68071-4582 | 68071-4582-3 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 68071-4582 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | ||
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68071-4582 | 68071-4582-3 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080706-006 | ALA-CORT | HYDROCORTISONE | 1% | CREAM / TOPICAL | AT | Approved before 1982 | |
| A080706-007 | ALA-CORT | HYDROCORTISONE | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A080706-006 | AT |
| A080706-007 | AT |
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 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A080706-006 | ALA-CORT | 1% | CREAM / TOPICAL | AT | Approved before 1982 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A080706-007 | ALA-CORT | 2.5% | CREAM / TOPICAL | AT | 2016-01-05 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A080706-006 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A080706-007 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080706-006 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080706-007 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A080706-006 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A080706-007 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080706-006 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080706-007 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080706-006 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080706-007 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080706-006 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080706-007 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080706-006 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080706-007 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080706-006 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080706-007 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080706-006 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080706-007 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A080706-006 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A080706-007 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080706-006 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080706-007 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080706-006 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080706-007 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080706-006 | AT | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080706-007 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A080706-006 | AT | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A080706-007 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080706-006 | AT | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080706-007 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A080706-006 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A080706-007 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A080706-006 | AT | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A080706-007 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A080706-006 | AT | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A080706-007 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A080706-006 | AT | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A080706-007 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A080706-006 | AT | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A080706-007 | AT | 1 | 782e0a99824c… |
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 | Bryant Ranch Prepack | 04758c46-0ca4-4852-acdc-1f8553ce2e6e | 2026-05-21 | Adverse reactions | 080706 ANDA080706 |
| Hydrocortisone | HYDROCORTISONE | Preferred Pharmaceuticals, Inc. | 026728d4-846b-4bd4-9183-ae6c4a714138 | 2026-05-11 | Adverse reactions | 080706 ANDA080706 |
| Hydrocortisone | HYDROCORTISONE | Sportpharm LLC | 78f43570-b6fd-42eb-bb9e-580abf79bf0d | 2026-04-24 | Adverse reactions | 080706 ANDA080706 |
| Hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 5e95eb82-40cd-411b-9006-c27b65db4b3f | 2026-03-25 | Adverse reactions | 080706 ANDA080706 |
| Hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 7f262fa3-4d2a-43f2-a4a7-f49f6034cf50 | 2026-03-25 | Adverse reactions | 080706 ANDA080706 |
| Hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 3d17e73a-15f5-4881-baf2-47a0149585fd | 2026-03-25 | Adverse reactions | 080706 ANDA080706 |
| Hydrocortisone | HYDROCORTISONE | A-S Medication Solutions | 5c4c3e02-5272-4a28-a9c8-1c5fa3ae181c | 2026-01-30 | Adverse reactions | 080706 ANDA080706 |
| Hydrocortisone | HYDROCORTISONE | Crown Laboratories | a84830ad-73dc-4a2e-b987-0a1103526535 | 2026-01-12 | Adverse reactions | 080706 ANDA080706 |
| Alacort | HYDROCORTISONE | Crown Laboratories | de000081-a245-4f6b-9e7c-e47d84b82338 | 2026-01-12 | Adverse reactions | 080706 ANDA080706 |
| Hydrocortisone | HYDROCORTISONE | ANI Pharmaceuticals, Inc. | b2918ac7-14b5-4372-9055-8caf6f4bcf37 | 2025-12-22 | Adverse reactions | 080706 ANDA080706 |
| Hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | b6808d2d-192c-4d70-a2e8-bf13375c0280 | 2025-11-05 | Adverse reactions | 080706 ANDA080706 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4582-3 | 2024-06-12 | C162847 | 48780-1 | ba0f9c33-4a73-a910-e053-dadaa90a0b85 | Hydrocortisone Cream USP 1%, 2.5% |
| 68071-4582-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4a73-a910-e053-dadaa90a0b85 | Hydrocortisone Cream USP 1%, 2.5% |
| 68071-4582-3 | 2021-02-22 | C162847 | 48780-1 | ba0f9c33-4a73-a910-e053-dadaa90a0b85 | Hydrocortisone Cream USP 1%, 2.5% |
| 68071-4582-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4a73-a910-e053-dadaa90a0b85 | Hydrocortisone Cream USP 1%, 2.5% |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-4582-3 | 68071458203 | 30 g in 1 BOX (68071-4582-3) | 30 g | 2018-09-28 | 0000-00-00 | No | No | Current |