astonea
- Product NDC
- 77338-305
- 11-digit product format
- 773380305
- Labeler code
- 77338
- Product ID
- 77338-305_1bbae087-0d0a-67d2-e063-6294a90a8320
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- ASTONEA LABS PRIVATE LIMITED
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-05-02
- Substance
- HYDROCORTISONE ACETATE
- 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
- astonea
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE ACETATE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X7931PO74 |
| Rxcui | 1043690 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 77338-305-02 | astonea | 0.9 g in 1 PACKET | CREAM | 0.9 | | 4 |
| 77338-305-03 | astonea | 28.3 g in 1 TUBE | CREAM | 28.3 | | 4 |
| 77338-305-06 | astonea | 454 g in 1 JAR | CREAM | 454 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 77338-305 | ASTONEA (HYDROCORTISONE) CREAM [ASTONEA LABS PRIVATE LIMITED] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240627_de09e859-c5fd-0cc5-e053-2a95a90a147e.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 |
|---|
| 77338-305-02 | 77338030502 | .9 g in 1 PACKET (77338-305-02) | | 2022-05-02 | 0000-00-00 | No | No | Current |
| 77338-305-03 | 77338030503 | 28.3 g in 1 TUBE (77338-305-03) | 28.3 g | 2022-05-02 | 0000-00-00 | No | No | Current |
| 77338-305-06 | 77338030506 | 454 g in 1 JAR (77338-305-06) | 454 g | 2022-05-02 | 0000-00-00 | No | No | Current |