What is NDC 53499-1391?

53499-1391 is the product NDC for Alpha Sh, Sanguinaria canadensis root 6 [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?

Alpha Sh (Sanguinaria canadensis root, Goldenseal, Silicon dioxide, Potassium chloride, Pulsatilla vulgaris).

What is the active ingredient?

Sanguinaria canadensis root, Goldenseal, Silicon dioxide, Potassium chloride, Pulsatilla vulgaris.

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 Alpha Sh?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alpha Sh NDC 53499-1391 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53499-1391Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53499-1391Add 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
53499-1391-1	53499139101	4 BLISTER PACK in 1 BOX (53499-1391-1) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 18, 2011

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): Alpha Sh
Generic name (nonproprietary): sanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride, pulsatilla vulgaris
Active ingredients: Sanguinaria canadensis root — 6 [hp_X]/1Goldenseal — 6 [hp_X]/1Silicon dioxide — 6 [hp_X]/1Potassium chloride — 3 [hp_X]/1Pulsatilla vulgaris — 6 [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: Aug 18, 2011
Marketing end: Jan 31, 2027
Other FDA classes: Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)
Identifiers: Product ID 53499-1391_99987865-e648-4746-ab77-ff24708d2a8eSPL ID 99987865-e648-4746-ab77-ff24708d2a8eSPL set ID 94de9ce3-6ee9-4322-bda2-0b4391f09d87UNII N9288CD508, ZW3Z11D0JV, ETJ7Z6XBU4, 660YQ98I10, I76KB35JEVUPC 0308078013909
Pharmacologic class: Osmotic Laxative; Potassium Salt

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

N453499139101 followed by a unit qualifier and the quantity

Package 53499-1391-01. 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 22, 2022.

Indications (excerpt from the label)

Indications and Usage Temporarily relieves these symptoms: helps decongest sinus openings and sinus passages, shrinks swollen nasal membranse, promotes sinus drainage.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53499-1391

What is NDC 53499-1391?: 53499-1391 is the product NDC for Alpha Sh, Sanguinaria canadensis root 6 [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?: Alpha Sh (Sanguinaria canadensis root, Goldenseal, Silicon dioxide, Potassium chloride, Pulsatilla vulgaris).
What is the active ingredient?: Sanguinaria canadensis root, Goldenseal, Silicon dioxide, Potassium chloride, Pulsatilla vulgaris.
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 Alpha Sh?: 1 other product NDC are listed under this name. See all Alpha Sh 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 Alpha Sh NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Alpha Shsanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride, pulsatilla vulgaris	Sanguinaria canadensis root 6 [hp_X]/1 + 4 more ingredients	TabletSublingual	Schwabe Mexico, S.A. de C.V.	68466-4191	68466-4191-01