What is NDC 0054-0668?

0054-0668 is the product NDC for Alvimopan, Alvimopan 12 mg/1 capsule, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Alvimopan?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alvimopan NDC 0054-0668 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0668Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0668Add 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
0054-0668-82	00054066882	6 BLISTER PACK in 1 CARTON (0054-0668-82) / 5 CAPSULE in 1 BLISTER PACKMarketed from Feb 6, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Alvimopan
Generic name (nonproprietary): alvimopan
Active ingredients: Alvimopan — 12 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217753
Marketing start: Feb 6, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 0054-0668_89b02f3c-d8da-4b1f-9847-859c4efffabbSPL ID 89b02f3c-d8da-4b1f-9847-859c4efffabbSPL set ID 59ef406b-79db-4efd-b993-08b937ac682bRxCUI 799835UNII 677C126AET
Pharmacologic class: Opioid Antagonist

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400054066882 followed by a unit qualifier and the quantity

Package 00054-0668-82. 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 Oct 24, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. Alvimopan capsules are an opioid antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0668

What is NDC 0054-0668?: 0054-0668 is the product NDC for Alvimopan, Alvimopan 12 mg/1 capsule, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Alvimopan.
What is the active ingredient?: Alvimopan.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alvimopan?: 3 other product NDCs are listed under this name. See all Alvimopan 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 Alvimopan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Alvimopan	Alvimopan 12 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-870	51407-0870-33
Alvimopan	Alvimopan 12 mg/1	CapsuleOral	Par Health USA, LLC	0254-3012	00254-3012-55
Alvimopan	Alvimopan 12 mg/1	CapsuleOral	Actavis Pharma, Inc.	0591-2312	00591-2312-15

Other NDCs under ANDA 217753

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

FDA NDC Directory listings under ANDA 217753
Product	Strength	Form · route	Labeler	Product NDC
Alvimopan	Alvimopan 12 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-870