Proctocort
- Product NDC
- 65649-501
- 11-digit product format
- 656490501
- Labeler code
- 65649
- Product ID
- 65649-501_62bfc47a-1d14-4dd2-8020-56e01f4e89a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCORTISONE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Salix Pharmaceuticals, Inc
- Application
- ANDA080706
- Marketing category
- ANDA
- Marketing start
- 2004-06-01
- Substance
- HYDROCORTISONE
- Active strength
- 10 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
- Proctocort
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 106258, 1865144 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65649-501-30 | Proctocort | 1 in 1 CARTON | CREAM | 1 | | 5 |
| 65649-501-30 | Proctocort | 28.35 g in 1 TUBE | CREAM | 28.35 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65649-501 | PROCTOCORT (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20200110_8c318d15-30e4-4395-9aa9-4157d349fe70.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 |
|---|
| 65649-501-30 | 65649050130 | 1 TUBE in 1 CARTON (65649-501-30) / 28.35 g in 1 TUBE | 1 tube | 2004-06-01 | 0000-00-00 | No | No | Current |