What is NDC 0378-1813?

0378-1813 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium 125 ug/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levothyroxine Sodium NDC 0378-1813 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-1813Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-1813Add 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 NDC	11-digit (billing)	Package	Copy
0378-1813-10	00378181310	1000 TABLET in 1 BOTTLE, PLASTIC (0378-1813-10)Marketed from Nov 1, 2002
0378-1813-77	00378181377	90 TABLET in 1 BOTTLE, PLASTIC (0378-1813-77)Marketed from May 27, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 125 ug/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076187
Marketing start: Nov 1, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Thyroxine (Chemical structure)
Identifiers: Product ID 0378-1813_ca193039-55b1-4a7e-aa67-c4bff4f9f5b0SPL ID ca193039-55b1-4a7e-aa67-c4bff4f9f5b0SPL set ID e95720f2-91c9-a6d0-f7d5-8bcb94d07bbcRxCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270UNII 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

N400378181310 followed by a unit qualifier and the quantity

Package 00378-1813-10. 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 Apr 15, 2024. 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 0378-1813

What is NDC 0378-1813?: 0378-1813 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium 125 ug/1 tablet, listed with the FDA by Mylan 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Levothyroxine Sodium	Levothyroxine sodium .05 mg/1	TabletOral	Coupler LLC	67046-0819	67046-0819-03
Levothyroxine Sodium	Levothyroxine sodium .137 mg/1	TabletOral	Coupler LLC	67046-0972	67046-0972-03
Levothyroxine Sodium	Levothyroxine sodium .2 mg/1	TabletOral	Coupler LLC	67046-0387	67046-0387-03
Levothyroxine Sodium	Levothyroxine sodium .125 mg/1	TabletOral	Coupler LLC	67046-0951	67046-0951-03
Levothyroxine Sodium	Levothyroxine sodium 100 ug/1	TabletOral	Coupler LLC	67046-1679	67046-1679-03
Levothyroxine Sodium	Levothyroxine sodium .175 mg/1	TabletOral	Coupler LLC	67046-0517	67046-0517-03
Levothyroxine Sodium	Levothyroxine sodium .15 mg/1	TabletOral	Coupler LLC	67046-0515	67046-0515-03
Levothyroxine Sodium	Levothyroxine sodium .1 mg/1	TabletOral	Coupler LLC	67046-0569	67046-0569-03
Levothyroxine Sodium	Levothyroxine sodium .075 mg/1	TabletOral	Coupler LLC	67046-0801	67046-0801-03
Levothyroxine Sodium	Levothyroxine sodium .112 mg/1	TabletOral	Coupler LLC	67046-0290	67046-0290-03

All 522 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
Product	Strength	Form · route	Labeler	Product NDC
Levothyroxine Sodium	Levothyroxine sodium 137 ug/1	TabletOral	Mylan Institutional Inc.	42292-041
Levothyroxine Sodium	Levothyroxine sodium 88 ug/1	TabletOral	Mylan Institutional Inc.	42292-038
Levothyroxine Sodium	Levothyroxine sodium 112 ug/1	TabletOral	Mylan Institutional Inc.	42292-039
Levothyroxine Sodium	Levothyroxine sodium 175 ug/1	TabletOral	Mylan Institutional Inc.	42292-040
Levothyroxine Sodium	Levothyroxine sodium 200 ug/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1819
Levothyroxine Sodium	Levothyroxine sodium 112 ug/1	TabletOral	Northwind Health Company, LLC	51655-604
Levothyroxine Sodium	Levothyroxine sodium 300 ug/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1821
Levothyroxine Sodium	Levothyroxine sodium 125 ug/1	TabletOral	Cardinal Health 107, LLC	55154-4376
Levothyroxine Sodium	Levothyroxine sodium 150 ug/1	TabletOral	Cardinal Health 107, LLC	55154-4377
Levothyroxine Sodium	Levothyroxine sodium 137 ug/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1823
Levothyroxine Sodium	Levothyroxine sodium 100 ug/1	TabletOral	Cardinal Health 107, LLC	55154-5381
Levothyroxine Sodium	Levothyroxine sodium 25 ug/1	TabletOral	Cardinal Health 107, LLC	55154-5362
Levothyroxine Sodium	Levothyroxine sodium 50 ug/1	TabletOral	Cardinal Health 107, LLC	55154-5380
Levothyroxine Sodium	Levothyroxine sodium 75 ug/1	TabletOral	Cardinal Health 107, LLC	55154-5395
Levothyroxine Sodium	Levothyroxine sodium 125 ug/1	TabletOral	Mylan Institutional Inc.	51079-443
Levothyroxine Sodium	Levothyroxine sodium 50 ug/1	TabletOral	Mylan Institutional Inc.	51079-440
Levothyroxine Sodium	Levothyroxine sodium 75 ug/1	TabletOral	Mylan Institutional Inc.	51079-441
Levothyroxine Sodium	Levothyroxine sodium 100 ug/1	TabletOral	Mylan Institutional Inc.	51079-442
Levothyroxine Sodium	Levothyroxine sodium 25 ug/1	TabletOral	Mylan Institutional Inc.	51079-444
Levothyroxine Sodium	Levothyroxine sodium 150 ug/1	TabletOral	Mylan Institutional Inc.	51079-445

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