Prescription drug · ANDA

Liothyronine Sodium NDC 42794-018

Liothyronine sodium 5 ug/1 · Tablet · Oral · SIGMAPHARM LABORATORIES, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)42794-018Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42794-0018Add 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
42794-018-0242794001802100 TABLET in 1 BOTTLE (42794-018-02)Marketed from Dec 3, 2012
42794-018-06427940018061000 TABLET in 1 BOTTLE (42794-018-06)Marketed from Dec 3, 2012
42794-018-124279400181290 TABLET in 1 BOTTLE (42794-018-12)Marketed from May 1, 2018

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)
Liothyronine Sodium
Generic name (nonproprietary)
liothyronine sodium
Active ingredients
Liothyronine sodium — 5 ug/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200295
Marketing start
Listing expires
Other FDA classes
Triiodothyronine (Chemical structure)
Identifiers
Product ID 42794-018_f1f181e3-ceed-1d17-e053-2995a90af5cdSPL ID f1f181e3-ceed-1d17-e053-2995a90af5cdSPL set ID 38ef3766-bb9a-402e-9e4a-ad8bb5b26e4cRxCUI 903456, 903697, 903703UNII GCA9VV7D2NUPC 0342794018121, 0342794019128, 0342794020124
Pharmacologic class
l-Triiodothyronine

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

N442794001802 followed by a unit qualifier and the quantity

Package 42794-0018-02. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Liothyronine sodium is an L-triiodothyronine (T3) indicated for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer ( 1.2 ) Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy ( 1.3 ) Limitations of Use: - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200295

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

FDA NDC Directory listings under ANDA 200295
ProductStrengthForm · routeLabelerProduct NDC
Liothyronine SodiumLiothyronine sodium 5 ug/1TabletOralNuCare Pharmaceuticals,Inc.68071-3571
Liothyronine SodiumLiothyronine sodium 5 ug/1TabletOralA-S Medication Solutions50090-3131
Liothyronine SodiumLiothyronine sodium 5 ug/1TabletOralBryant Ranch Prepack71335-0341
Liothyronine SodiumLiothyronine sodium 25 ug/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-884
Liothyronine SodiumLiothyronine sodium 5 ug/1TabletOralPreferred Pharmaceuticals Inc.68788-7269
Liothyronine SodiumLiothyronine sodium 25 ug/1TabletOralSIGMAPHARM LABORATORIES, LLC42794-019
Liothyronine SodiumLiothyronine sodium 50 ug/1TabletOralSIGMAPHARM LABORATORIES, LLC42794-020
Liomnyliothyronine sodiumLiothyronine sodium 5 ug/1TabletOralSIGMAPHARM LABORATORIES, LLC42794-131
Liomnyliothyronine sodiumLiothyronine sodium 25 ug/1TabletOralSIGMAPHARM LABORATORIES, LLC42794-132
Liomnyliothyronine sodiumLiothyronine sodium 50 ug/1TabletOralSIGMAPHARM LABORATORIES, LLC42794-133
Liothyronine SodiumLiothyronine sodium 50 ug/1TabletOralBryant Ranch Prepack71335-9632
Liothyronine SodiumLiothyronine sodium 5 ug/1TabletOralProficient Rx LP71205-150
Liothyronine SodiumLiothyronine sodium 5 ug/1TabletOralASCLEMED USA INC.87063-080
Liothyronine SodiumLiothyronine sodium 25 ug/1TabletOralASCLEMED USA INC.87063-081
Liothyronine SodiumLiothyronine sodium 50 ug/1TabletOralASCLEMED USA INC.87063-082
Liothyronine SodiumLiothyronine sodium 25 ug/1TabletOralBryant Ranch Prepack71335-0166

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Liothyronine Sodium NDC 42794-018 | Med-Code