Acamprosate Calcium NDC 0378-6333

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-6333Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-6333Add 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
0378-6333-80	00378633380	180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80)Marketed from Sep 24, 2014

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): Acamprosate Calcium
Generic name (nonproprietary): acamprosate calcium enteric-coated
Active ingredients: Acamprosate calcium — 333 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200142
Marketing start: Sep 24, 2014
Listing expires: Dec 31, 2026
Identifiers: Product ID 0378-6333_e06868f1-f40b-4762-bd52-53a5ba825619SPL ID e06868f1-f40b-4762-bd52-53a5ba825619SPL set ID 75ddfd10-55b2-426e-bc74-3413cd0d7c94RxCUI 835726UNII 59375N1D0UUPC 0303786333806

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

N400378633380 followed by a unit qualifier and the quantity

Package 00378-6333-80. 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 17, 2022.

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)

Other NDCs under ANDA 200142

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

FDA NDC Directory listings under ANDA 200142
Product	Strength	Form · route	Labeler	Product NDC
Acamprosate Calciumacamprosate calcium enteric-coated	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8560

Acamprosate Calcium (acamprosate calcium enteric-coated) NDC 0378-6333