Prescription drug · NDA

Levothyroxine Sodium NDC 71205-261

Levothyroxine sodium .088 mg/1 · Tablet · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-261Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0261Add 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
71205-261-307120502613030 TABLET in 1 BOTTLE, PLASTIC (71205-261-30)Marketed from May 1, 2019
71205-261-607120502616060 TABLET in 1 BOTTLE, PLASTIC (71205-261-60)Marketed from May 1, 2019
71205-261-907120502619090 TABLET in 1 BOTTLE, PLASTIC (71205-261-90)Marketed from May 1, 2019

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 — .088 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021210
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 71205-261_e51f5772-f7d2-448f-83ac-c912fa794ec4SPL ID e51f5772-f7d2-448f-83ac-c912fa794ec4SPL set ID b81720f9-2836-4c1d-8691-0f6acef13316RxCUI 966253UNII 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

N471205026130 followed by a unit qualifier and the quantity

Package 71205-0261-30. 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 71205-261

What is NDC 71205-261?
71205-261 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium .088 mg/1 tablet, listed with the FDA by Proficient Rx LP. 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?
Proficient Rx LP, NDC labeler code 71205. 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 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 .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
Unithroidlevothyroxine sodiumLevothyroxine sodium 125 ug/1TabletOralAmneal Pharmaceuticals LLC60846-807

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