Prescription drug · ANDA

Levothyroxine Sodium NDC 68788-8793

Levothyroxine sodium .175 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8793Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8793Add 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
68788-8793-3687888793036878887930330 TABLET in 1 BOTTLE (68788-8793-3)Marketed from Dec 17, 2024
68788-8793-9687888793096878887930990 TABLET in 1 BOTTLE (68788-8793-9)Marketed from Dec 17, 2024

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)
Levothyroxine Sodium
Generic name (nonproprietary)
levothyroxine sodium
Active ingredients
Levothyroxine sodium — .175 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
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 68788-8793_a0ffe111-3574-4481-a732-b68a7d58ef71SPL ID a0ffe111-3574-4481-a732-b68a7d58ef71SPL set ID a0ffe111-3574-4481-a732-b68a7d58ef71RxCUI 966249UNII 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

N468788879303 followed by a unit qualifier and the quantity

Package 68788-8793-03. 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 in adult and pediatric patients, including neonates, 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 in adult and pediatric patients, including neonates, 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-sufficien…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8793

What is NDC 68788-8793?
68788-8793 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium .175 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 .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
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralProficient Rx LP82804-314

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