NDC codes

FDA NDC Directory
Product NDC (as listed)10135-751Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10135-0751Add 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
10135-751-12101350751121013507511212 SUPPOSITORY in 1 CARTON (10135-751-12)Marketed from Aug 1, 2022
10135-751-24101350751241013507512424 SUPPOSITORY in 1 CARTON (10135-751-24)Marketed from Aug 1, 2022

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 Acetate
Generic name (nonproprietary)
hydrocortisone acetate
Active ingredients
Hydrocortisone acetate — 25 mg/1
Dosage form
Suppository
Route
Rectal
Labeler
Marlex Pharmaceuticals, Inc.NDC labeler code 10135
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 10135-751_43805142-9337-8a32-e063-6294a90a66d7SPL ID 43805142-9337-8a32-e063-6294a90a66d7SPL set ID e60473f7-fd00-a477-e053-2a95a90ad4ddRxCUI 1291082UNII 3X7931PO74
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

N410135075112 followed by a unit qualifier and the quantity

Package 10135-0751-12. 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 Acetate Suppositories are indicated for use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10135-751

What is NDC 10135-751?
10135-751 is the product NDC for Hydrocortisone Acetate, Hydrocortisone acetate 25 mg/1 suppository, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydrocortisone Acetate.
What is the active ingredient?
Hydrocortisone acetate.
Who is the labeler?
Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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 Acetate?
25 other product NDCs are listed under this name. See all Hydrocortisone Acetate 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 Acetate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hydrocortisone AcetateHydrocortisone acetate 25 mg/1SuppositoryRectalPreferred Pharmaceuticals, Inc.68788-419068788-4190-0168788-4190-02
Hydrocortisone AcetateHydrocortisone acetate 25 mg/1SuppositoryRectalAARNA USA INC.82568-015082568-0150-0182568-0150-02
Hydrocortisone AcetateHydrocortisone acetate 30 mg/1SuppositoryRectalAARNA USA INC.82568-016082568-0160-01
Hydrocortisone AcetateHydrocortisone acetate 30 mg/1SuppositoryRectalWestminster Pharmaceuticals, LLC69367-26069367-0260-12
Hydrocortisone AcetateHydrocortisone acetate 25 mg/1SuppositoryRectalMajor Pharmaceuticals0904-734000904-7340-1200904-7340-24
Hydrocortisone AcetateHydrocortisone acetate 30 mg/1SuppositoryRectalRising Pharma Holdings, Inc.16571-16416571-0164-21
Hydrocortisone AcetateHydrocortisone acetate 25 mg/1SuppositoryRectalQUAGEN PHARMACEUTICALS LLC70752-16970752-0169-0270752-0169-23
Hydrocortisone AcetateHydrocortisone acetate 25 mg/1SuppositoryRectalPatrin Pharma Inc.39328-02939328-0029-1239328-0029-24
Hydrocortisone AcetateHydrocortisone acetate 30 mg/1SuppositoryRectalPatrin Pharma Inc.39328-12939328-0129-12
Hydrocortisone AcetateHydrocortisone acetate 25 mg/1SuppositoryRectalAPNAR PHARMA LP24689-10224689-0102-01

All 26 Hydrocortisone Acetate NDCs

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