What is NDC 68382-569?

68382-569 is the product NDC for acamprosate calcium, Acamprosate calcium 333 mg/1 tablet, delayed release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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 68382-569 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-569Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0569Add 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
68382-569-01	68382056901	100 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-01)Marketed from Jun 1, 2017
68382-569-05	68382056905	500 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-05)Marketed from Jun 1, 2017
68382-569-06	68382056906	30 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-06)Marketed from Jun 1, 2017
68382-569-10	68382056910	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-10)Marketed from Jun 1, 2017
68382-569-16	68382056916	90 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-16)Marketed from Jun 1, 2017
68382-569-28	68382056928	180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-28)Marketed from Jun 1, 2017

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: Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205995
Marketing start: Jun 1, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 68382-569_2e5f04a0-3e2d-494f-837b-18570b6a8546SPL ID 2e5f04a0-3e2d-494f-837b-18570b6a8546SPL set ID 9803db35-2600-4f42-80c1-43216fd1ba3dRxCUI 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

N468382056901 followed by a unit qualifier and the quantity

Package 68382-0569-01. 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 6, 2023.

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 ( 1 , 14 ). Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support ( 1 ). 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 aca…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-569

What is NDC 68382-569?: 68382-569 is the product NDC for acamprosate calcium, Acamprosate calcium 333 mg/1 tablet, delayed release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 6 package NDCs, 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?: Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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	Bionpharma Inc.,	69452-353	69452-0353-25
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 205995

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

FDA NDC Directory listings under ANDA 205995
Product	Strength	Form · route	Labeler	Product NDC
acamprosate calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-4616
acamprosate calcium	Acamprosate calcium 333 mg/1	Tablet, Delayed releaseOral	Zydus Lifesciences Limited	70771-1057