NDC codes

FDA NDC Directory
Product NDC (as listed)51079-441Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51079-0441Add 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
51079-441-2051079044120100 BLISTER PACK in 1 CARTON (51079-441-20) / 1 TABLET in 1 BLISTER PACK (51079-441-01)Marketed from Feb 5, 2007

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 — 75 ug/1
Dosage form
Tablet
Route
Oral
Labeler
Mylan Institutional Inc.NDC labeler code 51079
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076187
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 51079-441_3a864332-4c4d-08a5-e063-6294a90aaaffSPL ID 3a864332-4c4d-08a5-e063-6294a90aaaffSPL set ID 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6RxCUI 892246, 966220, 966221, 966222, 966224, 966225UNII 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

N451079044120 followed by a unit qualifier and the quantity

Package 51079-0441-20. 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 51079-441

What is NDC 51079-441?
51079-441 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium 75 ug/1 tablet, listed with the FDA by Mylan Institutional Inc.. 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?
Mylan Institutional Inc., NDC labeler code 51079. 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 .05 mg/1TabletOralCoupler LLC67046-081967046-0819-03
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 529 Levothyroxine Sodium NDCs

Other NDCs under ANDA 076187

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

FDA NDC Directory listings under ANDA 076187
ProductStrengthForm · routeLabelerProduct NDC
Levothyroxine SodiumLevothyroxine sodium 200 ug/1TabletOralMylan Pharmaceuticals Inc.0378-1819
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralCardinal Health 107, LLC55154-5381
Levothyroxine SodiumLevothyroxine sodium 25 ug/1TabletOralCardinal Health 107, LLC55154-5362
Levothyroxine SodiumLevothyroxine sodium 50 ug/1TabletOralCardinal Health 107, LLC55154-5380
Levothyroxine SodiumLevothyroxine sodium 75 ug/1TabletOralCardinal Health 107, LLC55154-5395
Levothyroxine SodiumLevothyroxine sodium 125 ug/1TabletOralMylan Pharmaceuticals Inc.0378-1813
Levothyroxine SodiumLevothyroxine sodium 150 ug/1TabletOralMylan Pharmaceuticals Inc.0378-1815
Levothyroxine SodiumLevothyroxine sodium 175 ug/1TabletOralMylan Pharmaceuticals Inc.0378-1817
Levothyroxine SodiumLevothyroxine sodium 50 ug/1TabletOralMylan Institutional Inc.51079-440
Levothyroxine SodiumLevothyroxine sodium 300 ug/1TabletOralMylan Pharmaceuticals Inc.0378-1821
Levothyroxine SodiumLevothyroxine sodium 150 ug/1TabletOralMylan Institutional Inc.51079-445
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralMylan Institutional Inc.51079-442
Levothyroxine SodiumLevothyroxine sodium 125 ug/1TabletOralMylan Institutional Inc.51079-443
Levothyroxine SodiumLevothyroxine sodium 25 ug/1TabletOralMylan Institutional Inc.51079-444
Levothyroxine SodiumLevothyroxine sodium 137 ug/1TabletOralMylan Pharmaceuticals Inc.0378-1823
Levothyroxine SodiumLevothyroxine sodium 88 ug/1TabletOralNorthwind Health Company, LLC51655-529
Levothyroxine SodiumLevothyroxine sodium 175 ug/1TabletOralMylan Institutional Inc.42292-040
Levothyroxine SodiumLevothyroxine sodium 88 ug/1TabletOralMylan Institutional Inc.42292-038
Levothyroxine SodiumLevothyroxine sodium 112 ug/1TabletOralMylan Institutional Inc.42292-039
Levothyroxine SodiumLevothyroxine sodium 137 ug/1TabletOralMylan Institutional Inc.42292-041

Showing 20 of 29.

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