Prescription drug · NDA AUTHORIZED GENERIC

Levothyroxine Sodium NDC 69238-1835

Levothyroxine sodium .112 mg/1 · Tablet · Oral · Amneal Pharmaceuticals NY LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)69238-1835Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-1835Add 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
69238-1835-169238183501100 TABLET in 1 BOTTLE, PLASTIC (69238-1835-1)Marketed from Dec 1, 2003
69238-1835-7692381835071000 TABLET in 1 BOTTLE, PLASTIC (69238-1835-7)Marketed from Dec 1, 2003

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 — .112 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021210
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 69238-1835_3a92e520-3da8-43be-9be2-63511c44b735SPL ID 3a92e520-3da8-43be-9be2-63511c44b735SPL set ID fca88c97-5cd4-4834-ba87-deb5bd637788RxCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270UNII 9J765S329GUPC 0369238184112, 0369238183719, 0369838123016
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

N469238183501 followed by a unit qualifier and the quantity

Package 69238-1835-01. 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)

INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatme…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-1835

What is NDC 69238-1835?
69238-1835 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium .112 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals NY LLC. 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?
Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 .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 NDA 021210

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

FDA NDC Directory listings under NDA 021210
ProductStrengthForm · routeLabelerProduct NDC
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8574
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralProficient Rx LP71205-222
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralProficient Rx LP71205-240
Levothyroxine SodiumLevothyroxine sodium .137 mg/1TabletOralProficient Rx LP71205-237
Levothyroxine SodiumLevothyroxine sodium .125 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8575
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralProficient Rx LP71205-242
Levothyroxine SodiumLevothyroxine sodium .175 mg/1TabletOralProficient Rx LP71205-255
Levothyroxine SodiumLevothyroxine sodium .088 mg/1TabletOralProficient Rx LP71205-261
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralNorthwind Health Company, LLC51655-453
Levothyroxine SodiumLevothyroxine sodium .137 mg/1TabletOralNorthwind Health Company, LLC51655-513
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralNorthwind Health Company, LLC51655-557
Levothyroxine SodiumLevothyroxine sodium .137 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8649
Unithroidlevothyroxine sodiumLevothyroxine sodium 75 ug/1TabletOralAmneal Pharmaceuticals LLC60846-803
Unithroidlevothyroxine sodiumLevothyroxine sodium 25 ug/1TabletOralAmneal Pharmaceuticals LLC60846-801
Unithroidlevothyroxine sodiumLevothyroxine sodium 50 ug/1TabletOralAmneal Pharmaceuticals LLC60846-802
Levothyroxine SodiumLevothyroxine sodium .15 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8650
Unithroidlevothyroxine sodiumLevothyroxine sodium 112 ug/1TabletOralAmneal Pharmaceuticals LLC60846-806
Unithroidlevothyroxine sodiumLevothyroxine sodium 88 ug/1TabletOralAmneal Pharmaceuticals LLC60846-804
Unithroidlevothyroxine sodiumLevothyroxine sodium 100 ug/1TabletOralAmneal Pharmaceuticals LLC60846-805
Unithroidlevothyroxine sodiumLevothyroxine sodium 175 ug/1TabletOralAmneal Pharmaceuticals LLC60846-810

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Levothyroxine Sodium NDC 69238-1835 | National Drug Code | Med-Code