What is NDC 0378-3000?

0378-3000 is the product NDC for Meclofenamate Sodium, Meclofenamate sodium 100 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Meclofenamate Sodium?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Meclofenamate Sodium NDC 0378-3000

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-3000Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-3000Add 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
0378-3000-01	0037830000100378300001	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3000-01)Marketed from Sep 3, 1986

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): Meclofenamate Sodium
Generic name (nonproprietary): meclofenamate sodium
Active ingredients: Meclofenamate sodium — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 071081
Marketing start: Sep 3, 1986
Listing expires: Dec 31, 2027
Identifiers: Product ID 0378-3000_4be1c27e-b52c-472c-8795-16af910fa26eSPL ID 4be1c27e-b52c-472c-8795-16af910fa26eSPL set ID 96f19af4-de8f-4fd7-90d8-55fe6ebdd81dRxCUI 618552, 618557UNII 94NJ818U2WUPC 0303783000015, 0303782150018

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

N400378300001 followed by a unit qualifier and the quantity

Package 00378-3000-01. 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 Apr 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of meclofenamate sodium capsules and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Meclofenamate sodium capsules are indicated: • For reduction of fever in adults • For relief of mild to moderate pain in adults • For relief of signs and symptoms of juvenile arthritis. • For relief of the signs and symptoms of rheumatoid arthritis • For relief of the signs and symptoms of osteoarthritis. • For treatment of primary dysmenorrhea. • For acute or long-term use in the rel…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-3000

What is NDC 0378-3000?: 0378-3000 is the product NDC for Meclofenamate Sodium, Meclofenamate sodium 100 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Meclofenamate Sodium.
What is the active ingredient?: Meclofenamate sodium.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Meclofenamate Sodium?: 1 other product NDC are listed under this name. See all Meclofenamate Sodium 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 Meclofenamate Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Meclofenamate Sodium	Meclofenamate sodium 50 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-2150	00378-2150-01

Other NDCs under ANDA 071081

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

FDA NDC Directory listings under ANDA 071081
Product	Strength	Form · route	Labeler	Product NDC
Meclofenamate Sodium	Meclofenamate sodium 50 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-2150