Prescription drug · ANDA
Hydrocortisone NDC 0316-0193
Hydrocortisone 25 mg/g · Cream · Topical · Crown Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0316-0193-16 | 0031601931600316019316 | 1 JAR in 1 CARTON (0316-0193-16) / 454 g in 1 JARMarketed from Jan 6, 2016 | |
| 0316-0193-20 | 0031601932000316019320 | 1 TUBE in 1 CARTON (0316-0193-20) / 20 g in 1 TUBEMarketed from Jan 6, 2016 | |
| 0316-0193-30 | 0031601933000316019330 | 1 TUBE in 1 CARTON (0316-0193-30) / 30 g in 1 TUBEMarketed from Jan 6, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Hydrocortisone
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Crown LaboratoriesNDC labeler code 0316
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080706
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0316-0193_48343bf7-453f-6b2e-e063-6394a90a05f6SPL ID 48343bf7-453f-6b2e-e063-6394a90a05f6SPL set ID a84830ad-73dc-4a2e-b987-0a1103526535RxCUI 106258, 310891UNII WI4X0X7BPJUPC 0303160193309, 0303160186011
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400316019316followed by a unit qualifier and the quantityPackage 00316-0193-16. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Topcial corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Excerpt only. Read the full label for complete information.
About NDC 0316-0193
- What is NDC 0316-0193?
- 0316-0193 is the product NDC for Hydrocortisone, Hydrocortisone 25 mg/g cream, listed with the FDA by Crown Laboratories. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocortisone.
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Crown Laboratories, NDC labeler code 0316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrocortisone?
- 171 other product NDCs are listed under this name. See all Hydrocortisone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocortisone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrocortisone | Hydrocortisone 1 g/100g | LotionTopical | Amazon.com Services LLC | 72288-469 | 72288-0469-25 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Solco Healthcare LLC | 43547-892 | 43547-0892-05 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Solco Healthcare LLC | 43547-893 | 43547-0893-10 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Solco Healthcare LLC | 43547-894 | 43547-0894-10 |
| Hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Amazon.com Services LLC | 72288-713 | 72288-0713-64 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-065 | 21922-0065-0521922-0065-30 |
| Hydrocortisone | Hydrocortisone 20 mg/g | GelTopical | Redmont Pharmaceuticals, LLC | 71741-455 | 71741-0455-31 |
| Hydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Sportpharm LLC | 85766-166 | 85766-0166-1085766-0166-25 |
| hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Sportpharm LLC | 85766-151 | 85766-0151-28 |
| Hydrocortisonehydrocortisone cream 1% | Hydrocortisone 1 g/100g | CreamTopical | Aldermed Inc. | 87236-004 | 87236-0004-09 |
Other NDCs under ANDA 080706
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Alacorthydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Crown Laboratories | 0316-0126 |
| Alacorthydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Crown Laboratories | 0316-0128 |
| Hydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Crown Laboratories | 0316-0186 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | A-S Medication Solutions | 50090-2452 |
| Hydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | ANI Pharmaceuticals, Inc. | 62559-430 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | ANI Pharmaceuticals, Inc. | 62559-431 |
| Hydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-1951 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-1952 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Preferred Pharmaceuticals, Inc. | 68788-8302 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2954 |
| Hydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1763 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1764 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Sportpharm LLC | 85766-085 |