hydrocortisone and acetic acid
- Product NDC
- 71656-064
- 11-digit product format
- 716560064
- Labeler code
- 71656
- Product ID
- 71656-064_339e0417-4d1a-e168-e063-6294a90a50bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone and acetic acid otic
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Saptalis Pharmaceuticals, LLC
- Application
- NDA012770
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-02-23
- Substance
- ACETIC ACID; HYDROCORTISONE
- Active strength
- 20.75; 10.375 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 | 20.75 mg/mL |
| HYDROCORTISONE | 10.375 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 |
|---|
| 71656-064-10 | hydrocortisone and acetic acid | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 71656-064-10 | hydrocortisone and acetic acid | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71656-064 | HYDROCORTISONE AND ACETIC ACID (HYDROCORTISONE AND ACETIC ACID OTIC) SOLUTION [SAPTALIS PHARMACEUTICALS, LLC] | 3 | Current NDC, 2 package rows | 20250427_d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71656-064-10 | 71656006410 | 1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER | 2024-02-23 | No | No | Current |