NDC codes

FDA NDC Directory
Product NDC (as listed)75834-311Labeler and product segments. Claims need a package NDC.
Product NDC at billing width75834-0311Add 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
75834-311-017583403110175834031101100 TABLET in 1 BOTTLE (75834-311-01)Marketed from Jul 24, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Niva Thyroid
Generic name (nonproprietary)
thyroid, porcine
Active ingredients
Thyroid — 30 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Nivagen Pharmaceuticals, Inc.NDC labeler code 75834
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 75834-311_1cce3de8-0aa9-4f05-9104-a84b7d91dd68SPL ID 1cce3de8-0aa9-4f05-9104-a84b7d91dd68SPL set ID eae7789a-d85d-4b04-a680-e688a371ebeeRxCUI 198278, 208545, 313385, 313387, 313391, 313393, 314267, 315235, 2642816, 2642818, 2642820, 2642822, 2642824, 2642826, 2642828, 2642830UNII 6RV024OAUQUPC 0375834316017, 0375834312019, 0375834313016, 0375834314013, 0375834317014, 0375834315010, 0375834310015, 0375834311012

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

N475834031101 followed by a unit qualifier and the quantity

Package 75834-0311-01. 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)

INDICATIONS & USAGE Niva Thyroid tablets are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS ). 2. As pituitary…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 75834-311

What is NDC 75834-311?
75834-311 is the product NDC for Niva Thyroid, Thyroid 30 mg/1 tablet, listed with the FDA by Nivagen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Niva Thyroid (Thyroid, porcine).
What is the active ingredient?
Thyroid.
Who is the labeler?
Nivagen Pharmaceuticals, Inc., NDC labeler code 75834. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Niva Thyroid?
8 other product NDCs are listed under this name. See all Niva Thyroid 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 Niva Thyroid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Niva Thyroidthyroid, porcineThyroid 90 mg/1TabletOralBryant Ranch Prepack71335-280171335-2801-0171335-2801-0271335-2801-03
Niva Thyroidthyroid, porcineThyroid 15 mg/1TabletOralNivagen Pharmaceuticals, Inc.75834-31075834-0310-01
Niva Thyroidthyroid, porcineThyroid 60 mg/1TabletOralNivagen Pharmaceuticals, Inc.75834-31275834-0312-01
Niva Thyroidthyroid, porcineThyroid 90 mg/1TabletOralNivagen Pharmaceuticals, Inc.75834-31375834-0313-01
Niva Thyroidthyroid, porcineThyroid 120 mg/1TabletOralNivagen Pharmaceuticals, Inc.75834-31475834-0314-01
Niva Thyroidthyroid, porcineThyroid 180 mg/1TabletOralNivagen Pharmaceuticals, Inc.75834-31575834-0315-01
Niva Thyroidthyroid, porcineThyroid 240 mg/1TabletOralNivagen Pharmaceuticals, Inc.75834-31675834-0316-01
Niva Thyroidthyroid, porcineThyroid 300 mg/1TabletOralNivagen Pharmaceuticals, Inc.75834-31775834-0317-01

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