Prescription drug · ANDA

Levothyroxine Sodium NDC 72189-107

Levothyroxine sodium .075 mg/1 · Tablet · Oral · DIRECT RX

NDC codes

FDA NDC Directory
Product NDC (as listed)72189-107Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0107Add 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
72189-107-30721890107307218901073030 TABLET in 1 BOTTLE (72189-107-30)Marketed from May 18, 2020
72189-107-90721890107907218901079090 TABLET in 1 BOTTLE (72189-107-90)Marketed from May 18, 2020

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)
Levothyroxine Sodium
Generic name (nonproprietary)
levothyroxine sodium
Active ingredients
Levothyroxine sodium — .075 mg/1
Dosage form
Tablet
Route
Oral
Labeler
DIRECT RXNDC labeler code 72189
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209713
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 72189-107_1922dbd9-96de-8652-e063-6294a90a0afeSPL ID 1922dbd9-96de-8652-e063-6294a90a0afeSPL set ID a5f15022-1166-09fe-e053-2a95a90aa218RxCUI 892246, 966220, 966221, 966222, 966224, 966225, 966248, 966253, 966270UNII 9J765S329G
Pharmacologic class
l-Thyroxine

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

N472189010730 followed by a unit qualifier and the quantity

Package 72189-0107-30. 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)

Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-107

What is NDC 72189-107?
72189-107 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium .075 mg/1 tablet, listed with the FDA by DIRECT RX. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Levothyroxine Sodium.
What is the active ingredient?
Levothyroxine sodium.
Who is the labeler?
DIRECT RX, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Levothyroxine Sodium?
517 other product NDCs are listed under this name. See all Levothyroxine Sodium 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 Levothyroxine Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralCoupler LLC67046-081967046-0819-03
Levothyroxine SodiumLevothyroxine sodium .137 mg/1TabletOralCoupler LLC67046-097267046-0972-03
Levothyroxine SodiumLevothyroxine sodium .2 mg/1TabletOralCoupler LLC67046-038767046-0387-03
Levothyroxine SodiumLevothyroxine sodium .125 mg/1TabletOralCoupler LLC67046-095167046-0951-03
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralCoupler LLC67046-167967046-1679-03
Levothyroxine SodiumLevothyroxine sodium .175 mg/1TabletOralCoupler LLC67046-051767046-0517-03
Levothyroxine SodiumLevothyroxine sodium .15 mg/1TabletOralCoupler LLC67046-051567046-0515-03
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralCoupler LLC67046-056967046-0569-03
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralCoupler LLC67046-080167046-0801-03
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralCoupler LLC67046-029067046-0290-03

All 518 Levothyroxine Sodium NDCs

Other NDCs under ANDA 209713

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

FDA NDC Directory listings under ANDA 209713
ProductStrengthForm · routeLabelerProduct NDC
Levothyroxine SodiumLevothyroxine sodium .175 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8793
Levothyroxine SodiumLevothyroxine sodium .125 mg/1TabletOralAmerican Health Packaging60687-519
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralMajor Pharmaceuticals0904-6951
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralAmerican Health Packaging60687-453
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralNorthwind Health Company, LLC51655-923
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralProficient Rx LP82804-277
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralNorthwind Health Company, LLC51655-924
Levothyroxine SodiumLevothyroxine sodium .088 mg/1TabletOralProficient Rx LP82804-281
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralA-S Medication Solutions50090-7071
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralAmerican Health Packaging60687-464
Levothyroxine SodiumLevothyroxine sodium .088 mg/1TabletOralMajor Pharmaceuticals0904-6952
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralAmerican Health Packaging60687-475
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralProficient Rx LP82804-290
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralMajor Pharmaceuticals0904-6953
Levothyroxine SodiumLevothyroxine sodium .088 mg/1TabletOralAmerican Health Packaging60687-486
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralBryant Ranch Prepack71335-2549
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralAmerican Health Packaging60687-497
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralAmerican Health Packaging60687-508
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralMajor Pharmaceuticals0904-6954
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralCoupler LLC67046-0290

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