Prescription drug · ANDA
Hydrocortisone NDC 50268-407
Hydrocortisone 20 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-407-15 | 5026804071550268040715 | 50 BLISTER PACK in 1 BOX (50268-407-15) / 1 TABLET in 1 BLISTER PACK (50268-407-11)Marketed from Jan 31, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvPAKNDC labeler code 50268
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040646
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 50268-407_2b497b3c-577d-f786-e063-6294a90ad095SPL ID 2b497b3c-577d-f786-e063-6294a90ad095SPL set ID f3956208-291c-7374-e053-2a95a90a4628RxCUI 197782, 197783, 197787UNII WI4X0X7BPJ
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450268040715followed by a unit qualifier and the quantityPackage 50268-0407-15. 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 Hydrocortisone Tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected c…
Excerpt only. Read the full label for complete information.
About NDC 50268-407
- What is NDC 50268-407?
- 50268-407 is the product NDC for Hydrocortisone, Hydrocortisone 20 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, 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?
- AvPAK, NDC labeler code 50268. 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?
- 168 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 040646
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 |
|---|---|---|---|---|
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1696 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1697 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1700 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7188 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | AvPAK | 50268-405 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | AvPAK | 50268-406 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8455 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1989 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2044 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2018 |