What is NDC 16571-164?

16571-164 is the product NDC for Hydrocortisone Acetate, Hydrocortisone acetate 30 mg/1 suppository, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydrocortisone Acetate NDC 16571-164 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-164Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0164Add 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 NDC	11-digit (billing)	Package	Copy
16571-164-21	16571016421	12 SUPPOSITORY in 1 CARTON (16571-164-21)Marketed from Mar 1, 2024

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 — 30 mg/1
Dosage form: Suppository
Route: Rectal
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Mar 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 16571-164_11c6826c-5e54-4094-b5ba-02b24d1db3fcSPL ID 11c6826c-5e54-4094-b5ba-02b24d1db3fcSPL set ID de171b0a-3854-4aaa-889e-f2d999c0458cRxCUI 1291082, 1291085UNII 3X7931PO74UPC 0316571676217, 0316571164219
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

N416571016421 followed by a unit qualifier and the quantity

Package 16571-0164-21. 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 Feb 20, 2024.

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 anorectum, and pruritus ani.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-164

What is NDC 16571-164?: 16571-164 is the product NDC for Hydrocortisone Acetate, Hydrocortisone acetate 30 mg/1 suppository, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, 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?: Rising Pharma Holdings, Inc., NDC labeler code 16571. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydrocortisone Acetate	Hydrocortisone acetate 25 mg/1	SuppositoryRectal	Preferred Pharmaceuticals, Inc.	68788-4190	68788-4190-0168788-4190-02
Hydrocortisone Acetate	Hydrocortisone acetate 25 mg/1	SuppositoryRectal	AARNA USA INC.	82568-0150	82568-0150-0182568-0150-02
Hydrocortisone Acetate	Hydrocortisone acetate 30 mg/1	SuppositoryRectal	AARNA USA INC.	82568-0160	82568-0160-01
Hydrocortisone Acetate	Hydrocortisone acetate 30 mg/1	SuppositoryRectal	Westminster Pharmaceuticals, LLC	69367-260	69367-0260-12
Hydrocortisone Acetate	Hydrocortisone acetate 25 mg/1	SuppositoryRectal	Major Pharmaceuticals	0904-7340	00904-7340-1200904-7340-24
Hydrocortisone Acetate	Hydrocortisone acetate 25 mg/1	SuppositoryRectal	Marlex Pharmaceuticals, Inc.	10135-751	10135-0751-1210135-0751-24
Hydrocortisone Acetate	Hydrocortisone acetate 25 mg/1	SuppositoryRectal	QUAGEN PHARMACEUTICALS LLC	70752-169	70752-0169-0270752-0169-23
Hydrocortisone Acetate	Hydrocortisone acetate 25 mg/1	SuppositoryRectal	Patrin Pharma Inc.	39328-029	39328-0029-1239328-0029-24
Hydrocortisone Acetate	Hydrocortisone acetate 30 mg/1	SuppositoryRectal	Patrin Pharma Inc.	39328-129	39328-0129-12
Hydrocortisone Acetate	Hydrocortisone acetate 25 mg/1	SuppositoryRectal	APNAR PHARMA LP	24689-102	24689-0102-01

All 26 Hydrocortisone Acetate NDCs