Alkindi
- Product NDC
- 71863-110
- 11-digit product format
- 718630110
- Labeler code
- 71863
- Product ID
- 71863-110_4ffdccff-95d3-7c88-e063-6394a90a1c9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- Eton Pharmaceuticals, Inc.
- Application
- NDA213876
- Marketing category
- NDA
- Marketing start
- 2020-09-29
- Substance
- HYDROCORTISONE
- Active strength
- 1 mg/1
- 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
- Alkindi
- Brand name suffix
- Sprinkle
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 2399644, 2399650, 2399652, 2399654, 2399656, 2399658, 2399659, 2399661 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71863-110-50 | Alkindi Sprinkle | 50 in 1 BOTTLE, PLASTIC | GRANULE | 50 | | 20 |
| 71863-110-50 | Alkindi Sprinkle | 1 in 1 CARTON | GRANULE | 1 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71863-110 | ALKINDI SPRINKLE (HYDROCORTISONE) GRANULE ALKINDI SPRINKLE (HYDROCORTISONE) GRANULE [ETON PHARMACEUTICALS, INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250201_26c13a5f-7119-4c6a-bf10-fda4e07d7682.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71863-110-50 | 71863011050 | 1 BOTTLE, PLASTIC in 1 CARTON (71863-110-50) / 50 GRANULE in 1 BOTTLE, PLASTIC | 2020-09-29 | 0000-00-00 | No | No | Current |