Prescription drug · NDA

levothyroxine sodium NDC 68788-8648

Levothyroxine sodium 25 ug/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8648Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8648Add 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
68788-8648-36878886480330 TABLET in 1 BOTTLE (68788-8648-3)Marketed from May 3, 2024
68788-8648-96878886480990 TABLET in 1 BOTTLE (68788-8648-9)Marketed from May 3, 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 — 25 ug/1
Dosage form
Tablet
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021116
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 68788-8648_bd78156a-c5ec-4686-8b61-d97bf0bafae0SPL ID bd78156a-c5ec-4686-8b61-d97bf0bafae0SPL set ID 412fc3f4-d9e0-49c5-b042-a6010aea7e5eRxCUI 966220UNII 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

N468788864803 followed by a unit qualifier and the quantity

Package 68788-8648-03. 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 68788-8648

What is NDC 68788-8648?
68788-8648 is the product NDC for levothyroxine sodium, Levothyroxine sodium 25 ug/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?
528 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 .1 mg/1TabletOralCoupler LLC67046-056967046-0569-03
Levothyroxine SodiumLevothyroxine sodium .15 mg/1TabletOralCoupler LLC67046-051567046-0515-03
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralCoupler LLC67046-080167046-0801-03
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralCoupler LLC67046-082867046-0828-03

All 529 levothyroxine sodium NDCs

Other NDCs under NDA 021116

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

FDA NDC Directory listings under NDA 021116
ProductStrengthForm · routeLabelerProduct NDC
levothyroxine sodiumLevothyroxine sodium 200 ug/1TabletOralAlvogen, Inc.47781-668
levothyroxine sodiumLevothyroxine sodium 300 ug/1TabletOralAlvogen, Inc.47781-671
Levothyroxine SodiumLevothyroxine sodium 125 ug/1TabletOralDIRECT RX72189-160
levothyroxine sodiumLevothyroxine sodium 175 ug/1TabletOralAlvogen, Inc.47781-728
levothyroxine sodiumLevothyroxine sodium 50 ug/1TabletOralNuCare Pharmaceuticals,Inc.68071-5226
Levothyroxine SodiumLevothyroxine sodium 88 ug/1TabletOralDIRECT RX72189-163
levothyroxine sodiumLevothyroxine sodium 112 ug/1TabletOralAlvogen, Inc.47781-721
levothyroxine sodiumLevothyroxine sodium 75 ug/1TabletOralNuCare Pharmaceuticals,Inc.68071-5227
levothyroxine sodiumLevothyroxine sodium 50 ug/1TabletOralBryant Ranch Prepack71335-1502
Levothyroxine SodiumLevothyroxine sodium 150 ug/1TabletOralDIRECT RX72189-173
levothyroxine sodiumLevothyroxine sodium 150 ug/1TabletOralBryant Ranch Prepack71335-1512
levothyroxine sodiumLevothyroxine sodium 75 ug/1TabletOralBryant Ranch Prepack72162-1460
Levothyroxine SodiumLevothyroxine sodium 25 ug/1TabletOralDIRECT RX72189-174
levothyroxine sodiumLevothyroxine sodium 100 ug/1TabletOralNuCar Pharmaceuticals,Inc.68071-5235
levothyroxine sodiumLevothyroxine sodium 25 ug/1TabletOralBryant Ranch Prepack72162-1458
levothyroxine sodiumLevothyroxine sodium 100 ug/1TabletOralBryant Ranch Prepack72162-1462
levothyroxine sodiumLevothyroxine sodium 137 ug/1TabletOralBryant Ranch Prepack71335-1528
levothyroxine sodiumLevothyroxine sodium 125 ug/1TabletOralA-S Medication Solutions50090-4799
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralDIRECT RX72189-206
levothyroxine sodiumLevothyroxine sodium 75 ug/1TabletOralBryant Ranch Prepack71335-2967

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