NDC codes

FDA NDC Directory
Product NDC (as listed)62135-020Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0020Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
62135-020-07621350020077 BOTTLE in 1 CARTON (62135-020-07) / 60 mL in 1 BOTTLEMarketed from Sep 6, 2021
62135-020-21621350020213 CARTON in 1 BOX (62135-020-21) / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLEMarketed from Nov 18, 2021
62135-020-46621350020461 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

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

N462135002007 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under ANDA 075172
ProductStrengthForm · routeLabelerProduct NDC
HydrocortisoneHydrocortisone 100 mg/60mLSuspensionRectalHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc23155-926

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in