NDC codes

FDA NDC Directory
Product NDC (as listed)62559-138Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62559-0138Add 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
62559-138-07625590138077 BOTTLE in 1 BOX (62559-138-07) / 60 mL in 1 BOTTLE (62559-138-11)Marketed from Aug 16, 2012

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 — 100 mg/60mL
Dosage form
Enema
Route
Rectal
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 62559
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 016199
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 62559-138_a1e01470-3da0-4ede-af39-2cdf8943f55fSPL ID a1e01470-3da0-4ede-af39-2cdf8943f55fSPL set ID 40654d12-56e4-4489-be49-19c60ad918adRxCUI 310878UNII 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 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

N462559013807 followed by a unit qualifier and the quantity

Package 62559-0138-07. 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 62559-138

What is NDC 62559-138?
62559-138 is the product NDC for Hydrocortisone, Hydrocortisone 100 mg/60mL enema, listed with the FDA by ANI Pharmaceuticals, Inc.. 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?
ANI Pharmaceuticals, Inc., NDC labeler code 62559. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hydrocortisone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
HydrocortisoneHydrocortisone 1 g/100gLotionTopicalAmazon.com Services LLC72288-46972288-0469-25
HydrocortisoneHydrocortisone 5 mg/1TabletOralSolco Healthcare LLC43547-89243547-0892-05
HydrocortisoneHydrocortisone 10 mg/1TabletOralSolco Healthcare LLC43547-89343547-0893-10
HydrocortisoneHydrocortisone 20 mg/1TabletOralSolco Healthcare LLC43547-89443547-0894-10
HydrocortisoneHydrocortisone 1 g/100gCreamTopicalAmazon.com Services LLC72288-71372288-0713-64
HydrocortisoneHydrocortisone 25 mg/gCreamTopicalEncube Ethicals, Inc.21922-06521922-0065-0521922-0065-30
HydrocortisoneHydrocortisone 20 mg/gGelTopicalRedmont Pharmaceuticals, LLC71741-45571741-0455-31
HydrocortisoneHydrocortisone 10 mg/gCreamTopicalSportpharm LLC85766-16685766-0166-1085766-0166-25
hydrocortisoneHydrocortisone 1 g/100gCreamTopicalSportpharm LLC85766-15185766-0151-28
Hydrocortisonehydrocortisone cream 1%Hydrocortisone 1 g/100gCreamTopicalAldermed Inc.87236-00487236-0004-09

All 170 Hydrocortisone NDCs

Other NDCs under NDA 016199

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 016199
ProductStrengthForm · routeLabelerProduct NDC
CortenemahydrocortisoneHydrocortisone 100 mg/60mLEnemaRectalANI Pharmaceuticals, Inc.62559-111

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