SionBiotext Hydrocortisone
- Product NDC
- 68786-001
- 11-digit product format
- 687860001
- Labeler code
- 68786
- Product ID
- 68786-001_35074279-3e3d-2a74-e063-6294a90af26f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone Acetate 1%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sion Biotext Medical Ltd
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-13
- Substance
- HYDROCORTISONE ACETATE
- Active strength
- .1 g/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
- SionBiotext Hydrocortisone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE ACETATE | .1 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X7931PO74 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68786-001-28 | SionBiotext Hydrocortisone | 28.3 g in 1 BOX | CREAM | 28.3 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68786-001 | SIONBIOTEXT HYDROCORTISONE (HYDROCORTISONE ACETATE 1%) CREAM [SION BIOTEXT MEDICAL LTD] | 1 | Current NDC, 1 package rows | 20250515_35073eae-26fe-2bb5-e063-6294a90ab56a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68786-001-28 | 68786000128 | 28.3 g in 1 BOX (68786-001-28) | 28.3 g | 2025-05-13 | No | No | Current |