Prescription drug · ANDA
Hydrocortisone Rectal Suspension (Retention) (Hydrocortisone) NDC 62135-020
Hydrocortisone 100 mg/60mL · Suspension · Rectal · Chartwell RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-020-07 | 62135002007 | 7 BOTTLE in 1 CARTON (62135-020-07) / 60 mL in 1 BOTTLEMarketed from Sep 6, 2021 | |
| 62135-020-21 | 62135002021 | 3 CARTON in 1 BOX (62135-020-21) / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLEMarketed from Nov 18, 2021 | |
| 62135-020-46 | 62135002046 | 1 BOTTLE in 1 CARTON (62135-020-46) / 60 mL in 1 BOTTLEMarketed from Sep 6, 2021 |
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 Rectal Suspension (Retention)
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 100 mg/60mL
- Dosage form
- Suspension
- Route
- Rectal
- Labeler
- Chartwell RX LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075172
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62135-020_459c2035-71cd-e07e-e063-6394a90a5a3aSPL ID 459c2035-71cd-e07e-e063-6394a90a5a3aSPL set ID 3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8RxCUI 310878UNII WI4X0X7BPJUPC 0362135020217, 0362135020071, 0362135020460
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N462135002007followed by a unit qualifier and the quantityPackage 62135-0020-07. 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 Rectal Suspension, USP is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.
Excerpt only. Read the full label for complete information.
About NDC 62135-020
- What is NDC 62135-020?
- 62135-020 is the product NDC for Hydrocortisone Rectal Suspension (Retention), Hydrocortisone 100 mg/60mL suspension, listed with the FDA by Chartwell RX LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocortisone Rectal Suspension (Retention) (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 Rectal Suspension (Retention)?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 075172
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 100 mg/60mL | SuspensionRectal | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc | 23155-926 |