What is NDC 0378-5630?

0378-5630 is the product NDC for Sumatriptan Succinate, Sumatriptan succinate 25 mg/1 tablet, film coated, 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 Sumatriptan Succinate?

34 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sumatriptan Succinate NDC 0378-5630 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-5630Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-5630Add 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
0378-5630-59	00378563059	9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5630-59)Marketed from Aug 10, 2009

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): Sumatriptan Succinate
Generic name (nonproprietary): sumatriptan succinate
Active ingredients: Sumatriptan succinate — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077744
Marketing start: Aug 10, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers: Product ID 0378-5630_158dc1ce-c7cc-4897-98d7-39cc989f60b1SPL ID 158dc1ce-c7cc-4897-98d7-39cc989f60b1SPL set ID 1d2cd01c-05e7-44cf-a71d-0f474e826b7eRxCUI 313160, 313161, 315223UNII J8BDZ68989
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

N400378563059 followed by a unit qualifier and the quantity

Package 00378-5630-59. 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 Aug 26, 2026.

Indications (excerpt from the label)

Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. • Sumatriptan tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. Sumatriptan tablets are a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-5630

What is NDC 0378-5630?: 0378-5630 is the product NDC for Sumatriptan Succinate, Sumatriptan succinate 25 mg/1 tablet, film coated, 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?: Sumatriptan Succinate.
What is the active ingredient?: Sumatriptan succinate.
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 Sumatriptan Succinate?: 34 other product NDCs are listed under this name. See all Sumatriptan Succinate 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 Sumatriptan Succinate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sumatriptan Succinate	Sumatriptan succinate 4 mg/.5mL	InjectionSubcutaneous	Alembic Pharmaceuticals Limited	46708-656	46708-0656-0146708-0656-05
Sumatriptan Succinate	Sumatriptan succinate 6 mg/.5mL	InjectionSubcutaneous	Alembic Pharmaceuticals Limited	46708-657	46708-0657-0146708-0657-05
Sumatriptan Succinate	Sumatriptan succinate 4 mg/.5mL	InjectionSubcutaneous	Alembic Pharmaceuticals Inc.	62332-656	62332-0656-0162332-0656-05
Sumatriptan Succinate	Sumatriptan succinate 6 mg/.5mL	InjectionSubcutaneous	Alembic Pharmaceuticals Inc.	62332-657	62332-0657-0162332-0657-05
Sumatriptan Succinate	Sumatriptan succinate 6 mg/.5mL	InjectionSubcutaneous	Sun Pharmaceutical Industries, Inc.	47335-276	47335-0276-4047335-0276-41
Sumatriptan Succinate	Sumatriptan succinate 25 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-596	72189-0596-09
Sumatriptan Succinate	Sumatriptan succinate 6 mg/.5mL	InjectionSubcutaneous	NorthStar Rx LLC	72603-141	72603-0141-02
Sumatriptan Succinate	Sumatriptan succinate 6 mg/.5mL	InjectionSubcutaneous	Dr. Reddys Laboratories Inc.,	43598-768	43598-0768-23
Sumatriptan Succinate	Sumatriptan succinate 6 mg/.5mL	InjectionSubcutaneous	Sportpharm LLC	85766-238	85766-0238-02
Sumatriptan Succinate	Sumatriptan succinate 25 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-432	72189-0432-09

All 35 Sumatriptan Succinate NDCs

Other NDCs under ANDA 077744

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

FDA NDC Directory listings under ANDA 077744
Product	Strength	Form · route	Labeler	Product NDC
Sumatriptan Succinate	Sumatriptan succinate 50 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5631
Sumatriptan Succinate	Sumatriptan succinate 100 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5632
Sumatriptan Succinate	Sumatriptan succinate 25 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-011
Sumatriptan Succinate	Sumatriptan succinate 50 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-012
Sumatriptan Succinate	Sumatriptan succinate 100 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-013