Hydrocortisone
- Product NDC
- 49999-162
- 11-digit product format
- 499990162
- Labeler code
- 49999
- Product ID
- 49999-162_a239a410-be74-43f6-836b-a4e93bf06edb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
- Application
- ANDA089414
- Marketing category
- ANDA
- Marketing start
- 2012-02-06
- Marketing end
- 0000-00-00
- Substance
- HYDROCORTISONE
- Active strength
- 25 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 49999-162 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 49999-162 | 49999-162-30 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089414-001 | HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM / TOPICAL | AT | RS | 1986-12-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A089414-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A089414-001 | HYDROCORTISONE | 2.5% | CREAM / TOPICAL | AT | RS | 1986-12-16 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A089414-001 | AT | 1 | a50c72e98297… |
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 | Sportpharm LLC | ef9cf62a-5805-48bc-915e-c0e91a10837e | 2026-04-24 | Adverse reactions | 089414 ANDA089414 |
| Hydrocortisone Cream | HYDROCORTISONE CREAM | Direct_Rx | 364af43e-c1a9-3f03-e063-6294a90a14f5 | 2026-03-17 | Adverse reactions | 089414 ANDA089414 |
| Hydrocortisone | HYDROCORTISONE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | bcd103f3-3dc8-4394-b8fd-8f8ddb721f77 | 2026-01-28 | Adverse reactions | 089414 ANDA089414 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49999-162-30 | GM - Gram | 49999-162 | 7fe31013-ccf7-4f13-9d42-dfc97a97d2a4 | 1 | 2012-07-24 |