HYDROCORTISONE ACETATE
- Product NDC
- 75834-147
- 11-digit product format
- 758340147
- Labeler code
- 75834
- Product ID
- 75834-147_fe395d7c-ccaa-4f49-a902-70a9f6fce571
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCORTISONE ACETATE
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Nivagen Pharmaceuticals, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2020-05-15
- Substance
- HYDROCORTISONE ACETATE
- Active strength
- 25 mg/1
- 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 ACETATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE ACETATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X7931PO74 |
| Rxcui | 1291082 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 75834-147-12 | 2023-08-28 | C162847 | 48780-1 | c7ccaba7-1f32-fd44-e053-dadaa90aa01b | Hydrocortisone Acetate, 25 mg Rectal Suppositories |
| 75834-147-24 | 2023-08-28 | C162847 | 48780-1 | c7ccaba7-1f32-fd44-e053-dadaa90aa01b | Hydrocortisone Acetate, 25 mg Rectal Suppositories |
| 75834-147-12 | 2023-01-30 | C162847 | 48780-1 | c7ccaba7-1f32-fd44-e053-dadaa90aa01b | Hydrocortisone Acetate, 25 mg Rectal Suppositories |
| 75834-147-24 | 2023-01-30 | C162847 | 48780-1 | c7ccaba7-1f32-fd44-e053-dadaa90aa01b | Hydrocortisone Acetate, 25 mg Rectal Suppositories |
| 75834-147-12 | 2021-09-23 | C162847 | 48780-1 | c7ccaba7-1f32-fd44-e053-dadaa90aa01b | Hydrocortisone Acetate, 25 mg Rectal Suppositories |
| 75834-147-24 | 2021-09-23 | C162847 | 48780-1 | c7ccaba7-1f32-fd44-e053-dadaa90aa01b | Hydrocortisone Acetate, 25 mg Rectal Suppositories |
| 75834-147-12 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1f32-fd44-e053-dadaa90aa01b | Hydrocortisone Acetate, 25 mg Rectal Suppositories |
| 75834-147-24 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1f32-fd44-e053-dadaa90aa01b | Hydrocortisone Acetate, 25 mg Rectal Suppositories |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-147-06 | HYDROCORTISONE ACETATE | 6 in 1 BLISTER PACK | SUPPOSITORY | 6 | | 4 |
| 75834-147-12 | HYDROCORTISONE ACETATE | 2 in 1 CARTON | SUPPOSITORY | 2 | | 4 |
| 75834-147-24 | HYDROCORTISONE ACETATE | 4 in 1 CARTON | SUPPOSITORY | 4 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-147 | HYDROCORTISONE ACETATE SUPPOSITORY [NIVAGEN PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20230829_7743779d-1e42-4b23-bde5-0d77fe95bb2b.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 |
|---|
| 75834-147-06 | 75834014706 | 6 in 1 BLISTER PACK | | | | | | Historical |
| 75834-147-12 | 75834014712 | 2 BLISTER PACK in 1 CARTON (75834-147-12) / 6 SUPPOSITORY in 1 BLISTER PACK (75834-147-06) | 2 blister pack | 2020-05-15 | 0000-00-00 | No | No | Current |
| 75834-147-24 | 75834014724 | 4 BLISTER PACK in 1 CARTON (75834-147-24) / 6 SUPPOSITORY in 1 BLISTER PACK (75834-147-06) | 4 blister pack | 2020-05-15 | 0000-00-00 | No | No | Current |