What is NDC 69452-353?

69452-353 is the product NDC for Acamprosate Calcium, Acamprosate calcium 333 mg/1 tablet, delayed release, listed with the FDA by Bionpharma Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.

Bionpharma Inc.,, NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Acamprosate Calcium?

10 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acamprosate Calcium NDC 69452-353 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-353Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0353Add 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
69452-353-25	69452035325	180 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-353-25)Marketed from Dec 1, 2025

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): Acamprosate Calcium
Generic name (nonproprietary): acamprosate calcium
Active ingredients: Acamprosate calcium — 333 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Bionpharma Inc.,NDC labeler code 69452
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219904
Marketing start: Dec 1, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 69452-353_44732224-b730-9a24-e063-6394a90ac0c0SPL ID 44732224-b730-9a24-e063-6394a90ac0c0SPL set ID 4473326f-79f1-61b2-e063-6294a90a17a3RxCUI 835726UNII 59375N1D0U

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

N469452035325 followed by a unit qualifier and the quantity

Package 69452-0353-25. 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 Nov 25, 2025.

Indications (excerpt from the label)

Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69452-353

What is NDC 69452-353?: 69452-353 is the product NDC for Acamprosate Calcium, Acamprosate calcium 333 mg/1 tablet, delayed release, listed with the FDA by Bionpharma Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acamprosate Calcium.
What is the active ingredient?: Acamprosate calcium.
Who is the labeler?: Bionpharma Inc.,, NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acamprosate Calcium?: 10 other product NDCs are listed under this name. See all Acamprosate Calcium 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 Acamprosate Calcium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Acamprosate Calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	Somerset Therapeutics, LLC	70069-860	70069-0860-1870069-0860-30
acamprosate calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-4616	70518-4616-00
Acamprosate Calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8660	00615-8660-39
acamprosate calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-569	68382-0569-0168382-0569-0568382-0569-06+3 more
acamprosate calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	Zydus Lifesciences Limited	70771-1057	70771-1057-0070771-1057-0170771-1057-03+3 more
Acamprosate Calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	American Health Packaging	60687-121	60687-0121-25
Acamprosate Calciumacamprosate calcium enteric-coated	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	Mylan Pharmaceuticals Inc.	0378-6333	00378-6333-80
Acamprosate Calciumacamprosate calcium enteric-coated	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8560	00615-8560-39
Acamprosate Calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	Major Pharmaceuticals	0904-7213	00904-7213-04
Acamprosate Calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	Glenmark Pharmaceuticals Inc., USA	68462-435	68462-0435-1168462-0435-18

Other NDCs under ANDA 219904

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

FDA NDC Directory listings under ANDA 219904
Product	Strength	Form · route	Labeler	Product NDC
Acamprosate Calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8660