Prescription drug · ANDA
Hydrocortisone NDC 62135-551
Hydrocortisone 5 mg/1 · Tablet · Oral · Chartwell RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-551-60 | 62135055160 | 60 TABLET in 1 BOTTLE (62135-551-60)Marketed from Mar 13, 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC.NDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207029
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62135-551_459cb5d8-cc7d-abb1-e063-6294a90aa216SPL ID 459cb5d8-cc7d-abb1-e063-6294a90aa216SPL set ID 4b6edbc4-7afb-4fb5-a16e-66ce70916f09RxCUI 197782, 197787UNII WI4X0X7BPJUPC 0362135551605, 0362135552909
- 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
N462135055160followed by a unit qualifier and the quantityPackage 62135-0551-60. 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 62135-551
- What is NDC 62135-551?
- 62135-551 is the product NDC for Hydrocortisone, Hydrocortisone 5 mg/1 tablet, listed with the FDA by Chartwell RX, LLC.. 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?
- Chartwell RX, LLC., NDC labeler code 62135. 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?
- 169 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 207029
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 | PD-Rx Pharmaceuticals, Inc. | 72789-227 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-228 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | American Health Packaging | 60687-844 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | American Health Packaging | 60687-582 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Chartwell RX, LLC. | 62135-552 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-229 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-110 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Strides Pharma Inc. | 42543-972 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Strides Pharma Inc. | 42543-970 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Strides Pharma Inc. | 42543-971 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-970 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-971 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-972 |