Prescription drug · NDA AUTHORIZED GENERIC

Levothyroxine Sodium NDC 67046-1635

Levothyroxine sodium 75 ug/1 · Tablet · Oral · Coupler LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67046-1635Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-1635Add 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
67046-1635-36704616350330 TABLET in 1 BLISTER PACK (67046-1635-3)Marketed from Dec 30, 2025

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 — 75 ug/1
Dosage form
Tablet
Route
Oral
Labeler
Coupler LLCNDC labeler code 67046
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021342
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 67046-1635_472ed612-a109-7533-e063-6294a90acbaaSPL ID 472ed612-a109-7533-e063-6294a90acbaaSPL set ID 472ec9e7-c1db-bf8c-e063-6394a90a2c07RxCUI 966222UNII 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

N467046163503 followed by a unit qualifier and the quantity

Package 67046-1635-03. 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 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 induc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1635

What is NDC 67046-1635?
67046-1635 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium 75 ug/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?
521 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 522 Levothyroxine Sodium NDCs

Other NDCs under NDA 021342

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

FDA NDC Directory listings under NDA 021342
ProductStrengthForm · routeLabelerProduct NDC
Levothyroxine SodiumLevothyroxine sodium 25 ug/1TabletOralLannett Company, Inc0527-3280
Levothyroxine SodiumLevothyroxine sodium 50 ug/1TabletOralLannett Company, Inc0527-3281
Levothyroxine SodiumLevothyroxine sodium 75 ug/1TabletOralLannett Company, Inc0527-3282
Levothyroxine SodiumLevothyroxine sodium 88 ug/1TabletOralLannett Company, Inc0527-3283
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralLannett Company, Inc0527-3284
Levothyroxine SodiumLevothyroxine sodium 112 ug/1TabletOralLannett Company, Inc0527-3285
Levothyroxine SodiumLevothyroxine sodium 125 ug/1TabletOralLannett Company, Inc0527-3286
Levothyroxine SodiumLevothyroxine sodium 137 ug/1TabletOralLannett Company, Inc0527-3287
Levothyroxine SodiumLevothyroxine sodium 150 ug/1TabletOralLannett Company, Inc0527-3288
Levothyroxine SodiumLevothyroxine sodium 175 ug/1TabletOralLannett Company, Inc0527-3289
Levothyroxine SodiumLevothyroxine sodium 200 ug/1TabletOralLannett Company, Inc0527-3290
Levothyroxine SodiumLevothyroxine sodium 300 ug/1TabletOralLannett Company, Inc0527-3291
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralA-S Medication Solutions50090-5654
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralA-S Medication Solutions50090-6573
Levothyroxine SodiumLevothyroxine sodium 50 ug/1TabletOralA-S Medication Solutions50090-6594
Levothyroxine SodiumLevothyroxine sodium 137 ug/1TabletOralNorthwind Health Company, LLC51655-128
Levothyroxine SodiumLevothyroxine sodium 50 ug/1TabletOralNorthwind Health Company, LLC51655-532
Levothyroxine SodiumLevothyroxine sodium 175 ug/1TabletOralNorthwind Health Company, LLC51655-537
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralNorthwind Health Company, LLC51655-544
Levothyroxine SodiumLevothyroxine sodium 75 ug/1TabletOralNorthwind Health Company, LLC51655-576

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