Proctosol-HC
- Product NDC
- 10631-407
- 11-digit product format
- 106310407
- Labeler code
- 10631
- Product ID
- 10631-407_38f87659-b6da-4111-e063-6294a90a522d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA088799
- Marketing category
- ANDA
- Marketing start
- 2005-04-28
- Substance
- HYDROCORTISONE
- Active strength
- 25 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Proctosol-HC
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 310891, 1540356 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10631-407-01 | Proctosol-HC | 1 in 1 CARTON | CREAM | 1 | | 7 |
| 10631-407-01 | Proctosol-HC | 28.35 g in 1 TUBE | CREAM | 28.35 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10631-407 | PROCTOSOL-HC (HYDROCORTISONE) CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20210113_565284e7-4994-486b-8267-18bd166655ac.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 |
|---|
| 10631-407-01 | 10631040701 | 1 TUBE in 1 CARTON (10631-407-01) / 28.35 g in 1 TUBE | 1 tube | 2005-04-28 | 0000-00-00 | No | No | Current |