Proctozone
- Product NDC
- 64980-301
- Requested package NDC
- 64980-301-30
- 11-digit product format
- 649800301
- Labeler code
- 64980
- Product ID
- 64980-301_0c61d2ad-0795-455a-a720-a81df1a0b0e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA089682
- Marketing category
- ANDA
- Marketing start
- 2012-05-01
- 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
- 2020-12-31
- 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 package | package | 64980-301 | 64980-301-30 | 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 |
|---|---|---|---|---|---|---|---|
| A089682-001 | HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM / TOPICAL | 1988-03-10 |
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 | A089682-001 | HYDROCORTISONE | 2.5% | CREAM / TOPICAL | 1988-03-10 | 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 | NuCare Pharmaceuticals,Inc. | 720357e2-6f01-737d-e053-2a95a90ae54b | 2024-06-10 | Adverse reactions | 089682 ANDA089682 |
| Hydrocortisone | HYDROCORTISONE | A-S Medication Solutions | 5ee2f62a-d8d5-4efd-bf6f-f79c10855631 | 2023-11-22 | Adverse reactions | 089682 ANDA089682 |
| Hydrocortisone | HYDROCORTISONE | Proficient Rx LP | d50240db-f630-4008-a272-55ba5c991304 | 2022-07-01 | Adverse reactions | 089682 ANDA089682 |
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64980-301-30 | GM - Gram | 64980-301 | b0cd9ecc-6d12-4b8e-99a8-ff0e9bc0e8ea | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310891 | hydrocortisone 2.5 % Topical Cream | PSN | d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3 | 1 |
| 1440936 | Proctozone HC 2.5 % Topical Cream | PSN | d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3 | 1 |
| 1440936 | hydrocortisone 25 MG/ML Topical Cream [Proctozone HC] | SBD | d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3 | 1 |
| 310891 | hydrocortisone 25 MG/ML Topical Cream | SCD | d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3 | 1 |
| 310891 | hydrocortisone 2.5 % Topical Cream | SY | d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3 | 1 |
| 1440936 | Proctozone HC 2.5 % Topical Cream | SY | d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3 | 1 |
| 1440936 | Proctozone HC 25 MG/ML Topical Cream | SY | d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64980-301-30 | 64980030130 | 1 TUBE in 1 CARTON (64980-301-30) > 30 g in 1 TUBE | 1 tube | 2012-05-01 | 0000-00-00 | No | No | Current |