NDC codes

FDA NDC Directory
Product NDC (as listed)54973-3162Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54973-3162Add 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
54973-3162-1549733162011 BOTTLE, PLASTIC in 1 CARTON (54973-3162-1) / 50 TABLET, SOLUBLE in 1 BOTTLE, PLASTICMarketed from Jul 17, 2006
54973-3162-2549733162024 TABLET, SOLUBLE in 1 PACKET (54973-3162-2)Marketed from Jul 17, 2006

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)
Restful Legs
Generic name (nonproprietary)
arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc
Active ingredients
Arsenic trioxide — 12 [hp_X]/1Lycopodium clavatum spore — 6 [hp_X]/1Pulsatilla vulgaris — 6 [hp_X]/1Toxicodendron pubescens leaf — 6 [hp_X]/1Sulfur — 6 [hp_X]/1Zinc — 12 [hp_X]/1
Dosage form
Tablet, Soluble
Route
Oral
Labeler
Hyland's Inc.NDC labeler code 54973
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 54973-3162_58cd6c9a-33fc-24eb-e063-6394a90a6984SPL ID 58cd6c9a-33fc-24eb-e063-6394a90a6984SPL set ID 36e5843c-916a-425c-becc-15674cda7a65UNII S7V92P67HO, C88X29Y479, I76KB35JEV, 6IO182RP7A, 70FD1KFU70, J41CSQ7QDS

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

N454973316201 followed by a unit qualifier and the quantity

Package 54973-3162-01. 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 .

Indications (excerpt from the label)

Uses ■ Helps temporarily relieves occasional symptoms of: ■ agitation or compelling urge to jerk or move legs ■ itching, tingling, or crawling sensations in the legs

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54973-3162

What is NDC 54973-3162?
54973-3162 is the product NDC for Restful Legs, Arsenic trioxide 12 [hp_X]/1 + 5 more ingredients tablet, soluble, listed with the FDA by Hyland's Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Restful Legs (Arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc).
What is the active ingredient?
Arsenic trioxide, Lycopodium clavatum spore, Pulsatilla vulgaris, Toxicodendron pubescens leaf, Sulfur, Zinc.
Who is the labeler?
Hyland's Inc., NDC labeler code 54973. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Restful Legs?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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