hydrocortisone and acetic acid
- Product NDC
- 0713-0849
- 11-digit product format
- 007130849
- Labeler code
- 0713
- Product ID
- 0713-0849_106bf241-c85e-8985-e063-6394a90abffb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone and acetic acid
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA040609
- Marketing category
- ANDA
- Marketing start
- 2024-02-01
- Substance
- ACETIC ACID; HYDROCORTISONE
- Active strength
- 20; 10 mg/mL; mg/mL
- 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 and acetic acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETIC ACID | 20 mg/mL |
| HYDROCORTISONE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q40Q9N063P, WI4X0X7BPJ |
| Rxcui | 313786 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0849-09 | hydrocortisone and acetic acid | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 0713-0849-09 | hydrocortisone and acetic acid | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0849 | HYDROCORTISONE AND ACETIC ACID SOLUTION [COSETTE PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20240203_cef3713f-11f3-4723-9267-3d79855b49bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0713-0849-09 | 00713084909 | 1 BOTTLE in 1 CARTON (0713-0849-09) / 10 mL in 1 BOTTLE | 1 bottle | 2024-02-01 | No | No | Historical |