NDC codes

FDA NDC Directory
Product NDC (as listed)67046-0819Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-0819Add 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
67046-0819-36704608190330 TABLET in 1 BLISTER PACK (67046-0819-3)Marketed from Jul 6, 2026

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 — .05 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Coupler LLCNDC labeler code 67046
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 67046-0819_55f4b986-a31c-23da-e063-6394a90a0b58SPL ID 55f4b986-a31c-23da-e063-6394a90a0b58SPL set ID 55f4c679-86cb-b97f-e063-6294a90ad5efRxCUI 966221UNII 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

N467046081903 followed by a unit qualifier and the quantity

Package 67046-0819-03. 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-sufficient …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-0819

What is NDC 67046-0819?
67046-0819 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium .05 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?
Coupler LLC, NDC labeler code 67046. 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 .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
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralCoupler LLC67046-082867046-0828-03

All 529 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 .1 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3717
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralCoupler LLC67046-0569
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralA-S Medication Solutions50090-6825
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralA-S Medication Solutions50090-6824
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralMajor Pharmaceuticals0904-6949
Levothyroxine SodiumLevothyroxine sodium .125 mg/1TabletOralNuCarePharmaceuticals, Inc.68071-3692
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralProficient Rx LP82804-277
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralMajor Pharmaceuticals0904-6950
Levothyroxine SodiumLevothyroxine sodium .088 mg/1TabletOralProficient Rx LP82804-281
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3956
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralProficient Rx LP82804-290
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralMajor Pharmaceuticals0904-6951
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8896
Levothyroxine SodiumLevothyroxine sodium .088 mg/1TabletOralMajor Pharmaceuticals0904-6952
Levothyroxine SodiumLevothyroxine sodium .15 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3730
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralCoupler LLC67046-0801
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralCoupler LLC67046-0828
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralMajor Pharmaceuticals0904-6953
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralProficient Rx LP82804-314
Levothyroxine SodiumLevothyroxine sodium .137 mg/1TabletOralA-S Medication Solutions50090-7767

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