What is NDC 53499-3391?

53499-3391 is the product NDC for Migraide, Cyclamen purpurascens tuber 3 [hp_X]/1 + 4 more ingredients tablet, listed with the FDA by Schwabe North America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Migraide (Cyclamen purpurascens tuber, Black cohosh, Iris versicolor whole, Gelsemium sempervirens whole, Sanguinaria canadensis root).

What is the active ingredient?

Cyclamen purpurascens tuber, Black cohosh, Iris versicolor whole, Gelsemium sempervirens whole, Sanguinaria canadensis root.

Schwabe North America, Inc., NDC labeler code 53499. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Migraide?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Migraide NDC 53499-3391 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53499-3391Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53499-3391Add 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
53499-3391-1	5349933910153499339101	4 BLISTER PACK in 1 BOX (53499-3391-1) / 10 TABLET in 1 BLISTER PACKMarketed from Nov 9, 2021

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): Migraide
Generic name (nonproprietary): cyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root
Active ingredients: Cyclamen purpurascens tuber — 3 [hp_X]/1Black cohosh — 3 [hp_X]/1Iris versicolor whole — 4 [hp_X]/1Gelsemium sempervirens whole — 3 [hp_X]/1Sanguinaria canadensis root — 3 [hp_X]/1
Dosage form: Tablet
Route: Sublingual
Labeler: Schwabe North America, Inc.NDC labeler code 53499
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Nov 9, 2021
Marketing end: Jan 31, 2027
Identifiers: Product ID 53499-3391_bc629508-09ed-4ceb-b954-9dbc2c2d07abSPL ID bc629508-09ed-4ceb-b954-9dbc2c2d07abSPL set ID 0dc575dd-ef7e-4f91-a2b3-0ea3637a871eUNII G728143D8Q, K73E24S6X9, PYC571247P, R0519OZO3K, N9288CD508

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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N453499339101 followed by a unit qualifier and the quantity

Package 53499-3391-01. 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 Mar 24, 2022.

Indications (excerpt from the label)

Indications & Usage For the temporary relief of minor aches and pains associated with headaches or migraine headaches.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53499-3391

What is NDC 53499-3391?: 53499-3391 is the product NDC for Migraide, Cyclamen purpurascens tuber 3 [hp_X]/1 + 4 more ingredients tablet, listed with the FDA by Schwabe North America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Migraide (Cyclamen purpurascens tuber, Black cohosh, Iris versicolor whole, Gelsemium sempervirens whole, Sanguinaria canadensis root).
What is the active ingredient?: Cyclamen purpurascens tuber, Black cohosh, Iris versicolor whole, Gelsemium sempervirens whole, Sanguinaria canadensis root.
Who is the labeler?: Schwabe North America, Inc., NDC labeler code 53499. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Migraide?: 2 other product NDCs are listed under this name. See all Migraide 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 Migraide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Migraidecyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root	Cyclamen purpurascens tuber 3 [hp_X]/1 + 4 more ingredients	TabletSublingual, Sublingual	Schwabe Mexico, S.A. de C.V.	68466-3391	68466-3391-04
Migraidecyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root	Cyclamen purpurascens tuber 3 [hp_X]/1 + 4 more ingredients	TabletSublingual, Sublingual	Schwabe Mexico, S.A. de C.V.	68466-2391	—