Prescription drug · ANDA

Levothyroxine Sodium NDC 33342-396

Levothyroxine sodium 88 ug/1 · Tablet · Oral · Macleods Pharmaceuticals Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)33342-396Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0396Add 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
33342-396-103334203961090 TABLET in 1 BOTTLE (33342-396-10)Marketed from Dec 21, 2022
33342-396-1133342039611100 TABLET in 1 BOTTLE (33342-396-11)Marketed from Dec 21, 2022
33342-396-44333420396441000 TABLET in 1 BOTTLE (33342-396-44)Marketed from Jan 24, 2023

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 — 88 ug/1
Dosage form
Tablet
Route
Oral
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211417
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 33342-396_3a77ca51-7d8a-4755-aabc-3801cc772a10SPL ID 3a77ca51-7d8a-4755-aabc-3801cc772a10SPL set ID b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9RxCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270UNII 9J765S329GUPC 0333342393104, 0333342397102, 0333342404107, 0333342393111, 0333342400109, 0333342403100, 0333342393449, 0333342394101, 0333342402103, 0333342396105, 0333342395108, 0333342398109, 0333342399106
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

N433342039610 followed by a unit qualifier and the quantity

Package 33342-0396-10. 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 33342-396

What is NDC 33342-396?
33342-396 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium 88 ug/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 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?
Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 ANDA 211417

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

FDA NDC Directory listings under ANDA 211417
ProductStrengthForm · routeLabelerProduct NDC
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralA-S Medication Solutions50090-8062
Levothyroxine SodiumLevothyroxine sodium 125 ug/1TabletOralA-S Medication Solutions50090-8056
Levothyroxine SodiumLevothyroxine sodium 50 ug/1TabletOralNuCare Pharmaceuticals,Inc.68071-3996
Levothyroxine SodiumLevothyroxine sodium 200 ug/1TabletOralA-S Medication Solutions50090-8059
Levothyroxine SodiumLevothyroxine sodium 50 ug/1TabletOralA-S Medication Solutions50090-8060
Levothyroxine SodiumLevothyroxine sodium 175 ug/1TabletOralA-S Medication Solutions50090-8068
Levothyroxine SodiumLevothyroxine sodium 112 ug/1TabletOralA-S Medication Solutions50090-8065
Levothyroxine SodiumLevothyroxine sodium 25 ug/1TabletOralA-S Medication Solutions50090-8066
Levothyroxine SodiumLevothyroxine sodium 75 ug/1TabletOralA-S Medication Solutions50090-8070
Levothyroxine SodiumLevothyroxine sodium 137 ug/1TabletOralA-S Medication Solutions50090-8072
Levothyroxine SodiumLevothyroxine sodium 137 ug/1TabletOralA-S Medication Solutions50090-7801
Levothyroxine SodiumLevothyroxine sodium 137 ug/1TabletOralA-S Medication Solutions50090-7802
Levothyroxine SodiumLevothyroxine sodium 50 ug/1TabletOralNorthStar RxLLC72603-661
Levothyroxine SodiumLevothyroxine sodium 25 ug/1TabletOralNorthStar RxLLC72603-660
Levothyroxine SodiumLevothyroxine sodium 112 ug/1TabletOralNorthStar RxLLC72603-665
Levothyroxine SodiumLevothyroxine sodium 75 ug/1TabletOralNorthStar RxLLC72603-662
Levothyroxine SodiumLevothyroxine sodium 88 ug/1TabletOralNorthStar RxLLC72603-663
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralNorthStar RxLLC72603-664
Levothyroxine SodiumLevothyroxine sodium 175 ug/1TabletOralNorthStar RxLLC72603-669
Levothyroxine SodiumLevothyroxine sodium 50 ug/1TabletOralA-S Medication Solutions50090-7562

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