Procto-Med HC
- Product NDC
- 69315-312
- 11-digit product format
- 693150312
- Labeler code
- 69315
- Product ID
- 69315-312_614fdcc8-43c2-4c42-a7fe-016844f338d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCORTISONE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA085025
- Marketing category
- ANDA
- Marketing start
- 2020-02-14
- Substance
- HYDROCORTISONE
- Active strength
- 25 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Procto-Med HC
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 310891, 1790684 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-312-28 | Procto-Med HC | 1 in 1 CARTON | CREAM | 1 | | 8 |
| 69315-312-28 | Procto-Med HC | 28 g in 1 TUBE | CREAM | 28 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-312 | PROCTO-MED HC (HYDROCORTISONE) CREAM [LEADING PHARMA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241212_0682580e-aff8-4b67-99ba-a29ab7b433db.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69315-312-28 | 69315031228 | 1 TUBE in 1 CARTON (69315-312-28) / 28 g in 1 TUBE | 1 tube | 2020-02-14 | 0000-00-00 | No | No | Current |