Hydrocortisone and Acetic Acid
- Product NDC
- 51672-3007
- 11-digit product format
- 516723007
- Labeler code
- 51672
- Product ID
- 51672-3007_395a20ab-856b-3f08-e063-6294a90aa48e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone and Acetic Acid
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA088759
- Marketing category
- ANDA
- Marketing start
- 2005-04-28
- Substance
- ACETIC ACID; HYDROCORTISONE
- Active strength
- 20.8; 10.4 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 | 20.8 mg/mL |
| HYDROCORTISONE | 10.4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q40Q9N063P, WI4X0X7BPJ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-3007-1 | Hydrocortisone and Acetic Acid | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 6 |
| 51672-3007-1 | Hydrocortisone and Acetic Acid | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Acetic Acid | ACTIVE INGREDIENT | Q40Q9N063P | HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 2 | |
| Hydrocortisone | ACTIVE INGREDIENT | WI4X0X7BPJ | HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 2 | |
| Acetic Acid | ACTIVE MOIETY | Q40Q9N063P | HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 2 | |
| Hydrocortisone | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 2 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 2 | |
| benzethonium chloride | INACTIVE INGREDIENT | PH41D05744 | HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 2 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 2 | |
| propylene glycol diacetate | INACTIVE INGREDIENT | 5Z492UNF9O | HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 2 | |
| sodium acetate | INACTIVE INGREDIENT | 4550K0SC9B | HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-3007 | HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250112_6383c722-84e2-4719-a13d-19c54e3eefff.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51672-3007-1 | 51672300701 | 1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE | 1 bottle | 2005-04-28 | 0000-00-00 | No | No | Current |