Almotriptan Malate (almotriptan) NDC 0378-5246

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-5246Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-5246Add 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
0378-5246-85	00378524685	2 BLISTER PACK in 1 CARTON (0378-5246-85) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-5246-32)Marketed from Nov 10, 2015

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): Almotriptan Malate
Generic name (nonproprietary): almotriptan
Active ingredients: Almotriptan malate — 12.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205171
Marketing start: Nov 10, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers: Product ID 0378-5246_24da4379-1283-4c66-97bd-643b27a15368SPL ID 24da4379-1283-4c66-97bd-643b27a15368SPL set ID 35617039-9f33-401b-bac3-8f85c65fa2c7RxCUI 284204, 284205UNII PJP312605EUPC 0303785246855, 0303785245858
Pharmacologic class: Serotonin-1b and Serotonin-1d Receptor Agonist

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

N400378524685 followed by a unit qualifier and the quantity

Package 00378-5246-85. 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 May 9, 2017.

Indications (excerpt from the label)

Almotriptan tablets are a 5HT 1B/1D receptor agonist (triptan) indicated for: • Acute treatment of migraine attacks in adults with a history of migraine with or without aura ( 1.1 ) • Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more ( 1.1 ) Important Limitations: • Use only after a clear diagnosis of migraine has been established ( 1.2 ) • In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms was not established ( 1.2 ) • Not intended for the prophylactic therapy of migraine ( 1.2 ) • Not indicated for the treat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205171

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

FDA NDC Directory listings under ANDA 205171
Product	Strength	Form · route	Labeler	Product NDC
Almotriptan Malatealmotriptan	Almotriptan malate 6.25 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5245