hydrocortisone and acetic acid
- Product NDC
- 50383-901
- 11-digit product format
- 503830901
- Labeler code
- 50383
- Product ID
- 50383-901_9b68befb-ac5a-4db8-a8cf-24a89bbf3155
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone and acetic acid
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Akorn Operating Company LLC
- Application
- NDA012770
- Marketing category
- NDA
- Marketing start
- 2009-06-04
- Marketing end
- 0000-00-00
- Substance
- ACETIC ACID; HYDROCORTISONE
- Active strength
- 21 mg/mL; mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 50383-901-10 | hydrocortisone and acetic acid | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
| 50383-901-10 | hydrocortisone and acetic acid | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 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 [HI-TECH PHARMACAL CO., INC.] | 3 | |
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | HYDROCORTISONE AND ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| ACETIC ACID | ACTIVE MOIETY | Q40Q9N063P | HYDROCORTISONE AND ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE AND ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | HYDROCORTISONE AND ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| BENZETHONIUM CHLORIDE | INACTIVE INGREDIENT | PH41D05744 | HYDROCORTISONE AND ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCORTISONE AND ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| PROPYLENE GLYCOL DIACETATE | INACTIVE INGREDIENT | 5Z492UNF9O | HYDROCORTISONE AND ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | HYDROCORTISONE AND ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-901 | HYDROCORTISONE AND ACETIC ACID SOLUTION [AKORN OPERATING COMPANY LLC] | 6 | Legacy NDC, 2 package rows | 20221014_ffd1edc1-2f40-4b0a-a53a-9fb53b8d3184.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50383-901-10 | 50383090110 | 1 BOTTLE, DROPPER in 1 CARTON (50383-901-10) > 10 mL in 1 BOTTLE, DROPPER | 2009-06-04 | 0000-00-00 | No | No | Current |