Hydrocortisone Rectal Suspension (Retention)
- Product NDC
- 62135-020
- 11-digit product format
- 621350020
- Labeler code
- 62135
- Product ID
- 62135-020_459c2035-71cd-e07e-e063-6394a90a5a3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- SUSPENSION
- Route
- RECTAL
- Labeler
- Chartwell RX LLC
- Application
- ANDA075172
- Marketing category
- ANDA
- Marketing start
- 1999-12-03
- Substance
- HYDROCORTISONE
- Active strength
- 100 mg/60mL
- 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
- Hydrocortisone Rectal Suspension (Retention)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 100 mg/60mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 310878 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-020-07 | Hydrocortisone Rectal Suspension (Retention) | 60 mL in 1 BOTTLE | SUSPENSION | 60 | | 6 |
| 62135-020-07 | Hydrocortisone Rectal Suspension (Retention) | 7 in 1 CARTON | SUSPENSION | 7 | | 6 |
| 62135-020-21 | Hydrocortisone Rectal Suspension (Retention) | 3 in 1 BOX | SUSPENSION | 3 | | 6 |
| 62135-020-21 | Hydrocortisone Rectal Suspension (Retention) | 7 in 1 CARTON | SUSPENSION | 7 | | 6 |
| 62135-020-46 | Hydrocortisone Rectal Suspension (Retention) | 60 mL in 1 BOTTLE | SUSPENSION | 60 | | 6 |
| 62135-020-46 | Hydrocortisone Rectal Suspension (Retention) | 1 in 1 CARTON | SUSPENSION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-020 | HYDROCORTISONE RECTAL SUSPENSION (RETENTION) (HYDROCORTISONE) SUSPENSION [CHARTWELL RX LLC] | 5 | Current NDC, Legacy NDC, 6 package rows | 20241030_3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8.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 |
|---|
| 62135-020-07 | 62135002007 | 7 BOTTLE in 1 CARTON (62135-020-07) / 60 mL in 1 BOTTLE | 7 bottle | 2021-09-06 | 0000-00-00 | No | No | Current |
| 62135-020-21 | 62135002021 | 3 CARTON in 1 BOX (62135-020-21) / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE | 3 carton | 2021-11-18 | 0000-00-00 | No | No | Current |
| 62135-020-46 | 62135002046 | 1 BOTTLE in 1 CARTON (62135-020-46) / 60 mL in 1 BOTTLE | 1 bottle | 2021-09-06 | 0000-00-00 | No | No | Current |