NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0306Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0306Add 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 NDC11-digit (billing)PackageCopy
80425-0306-18042503060130 CAPSULE in 1 BOTTLE (80425-0306-1)Marketed from Apr 6, 2023
80425-0306-28042503060260 CAPSULE in 1 BOTTLE (80425-0306-2)Marketed from Apr 6, 2023
80425-0306-38042503060390 CAPSULE in 1 BOTTLE (80425-0306-3)Marketed from Apr 6, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Mefenamic Acid
Generic name (nonproprietary)
mefenamic acid
Active ingredients
Mefenamic acid — 250 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090562
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 80425-0306_2a9ba8f4-6cef-e827-e063-6394a90a0300SPL ID 2a9ba8f4-6cef-e827-e063-6394a90a0300SPL set ID f8b1a4a2-83fc-6b4b-e053-6394a90ac46aRxCUI 829500UNII 367589PJ2C

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

N480425030601 followed by a unit qualifier and the quantity

Package 80425-0306-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). Mefenamic acid is indicated: For relief of mild to moderate pain in patients ≥ 14 years of age, when therapy will not exceed one week (7 days). For treatment of primary dysmenorrhea.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0306

What is NDC 80425-0306?
80425-0306 is the product NDC for Mefenamic Acid, Mefenamic acid 250 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mefenamic Acid.
What is the active ingredient?
Mefenamic acid.
Who is the labeler?
Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mefenamic Acid?
5 other product NDCs are listed under this name. See all Mefenamic Acid 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 Mefenamic Acid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Mefenamic AcidMefenamic acid 250 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-042380425-0423-0180425-0423-0280425-0423-03
Mefenamic AcidMefenamic acid 250 mg/1CapsuleOralMisemer Pharmaceuticals, Inc0276-050900276-0509-30
Mefenamic AcidMefenamic acid 250 mg/1CapsuleOralLupin Pharmaceuticals, Inc.68180-18568180-0185-06
Mefenamic acidMefenamic acid 250 mg/1CapsuleOralBryant Ranch Prepack72162-238272162-2382-03
Mefenamic acidMefenamic acid 250 mg/1CapsuleOralMicro Labs Limited42571-25842571-0258-0142571-0258-30

Other NDCs under ANDA 090562

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

FDA NDC Directory listings under ANDA 090562
ProductStrengthForm · routeLabelerProduct NDC
Mefenamic acidMefenamic acid 250 mg/1CapsuleOralMicro Labs Limited42571-258
Mefenamic acidMefenamic acid 250 mg/1CapsuleOralBryant Ranch Prepack72162-2382

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