NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1512Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1512Add 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
71335-1512-17133515120130 TABLET in 1 BOTTLE (71335-1512-1)Marketed from Feb 18, 2020
71335-1512-271335151202100 TABLET in 1 BOTTLE (71335-1512-2)Marketed from Feb 18, 2020
71335-1512-37133515120390 TABLET in 1 BOTTLE (71335-1512-3)Marketed from Feb 18, 2020
71335-1512-47133515120460 TABLET in 1 BOTTLE (71335-1512-4)Marketed from Feb 18, 2020

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 — 150 ug/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021116
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 71335-1512_5dd258ee-53fd-4e60-b3c9-b3cfacd622bfSPL ID 5dd258ee-53fd-4e60-b3c9-b3cfacd622bfSPL set ID 9e3bffb9-f66e-4c73-befc-e60d769f6610RxCUI 892246, 892251, 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

N471335151201 followed by a unit qualifier and the quantity

Package 71335-1512-01. 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)

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 71335-1512

What is NDC 71335-1512?
71335-1512 is the product NDC for levothyroxine sodium, Levothyroxine sodium 150 ug/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
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 522 levothyroxine sodium NDCs

Other NDCs under NDA 021116

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

FDA NDC Directory listings under NDA 021116
ProductStrengthForm · routeLabelerProduct NDC
levothyroxine sodiumLevothyroxine sodium 25 ug/1TabletOralAlvogen, Inc.47781-640
levothyroxine sodiumLevothyroxine sodium 50 ug/1TabletOralAlvogen, Inc.47781-643
levothyroxine sodiumLevothyroxine sodium 75 ug/1TabletOralAlvogen, Inc.47781-646
levothyroxine sodiumLevothyroxine sodium 88 ug/1TabletOralAlvogen, Inc.47781-649
levothyroxine sodiumLevothyroxine sodium 100 ug/1TabletOralAlvogen, Inc.47781-651
levothyroxine sodiumLevothyroxine sodium 112 ug/1TabletOralAlvogen, Inc.47781-654
levothyroxine sodiumLevothyroxine sodium 125 ug/1TabletOralAlvogen, Inc.47781-657
levothyroxine sodiumLevothyroxine sodium 137 ug/1TabletOralAlvogen, Inc.47781-659
levothyroxine sodiumLevothyroxine sodium 150 ug/1TabletOralAlvogen, Inc.47781-662
levothyroxine sodiumLevothyroxine sodium 175 ug/1TabletOralAlvogen, Inc.47781-665
levothyroxine sodiumLevothyroxine sodium 200 ug/1TabletOralAlvogen, Inc.47781-668
levothyroxine sodiumLevothyroxine sodium 300 ug/1TabletOralAlvogen, Inc.47781-671
levothyroxine sodiumLevothyroxine sodium 112 ug/1TabletOralAlvogen, Inc.47781-721
levothyroxine sodiumLevothyroxine sodium 175 ug/1TabletOralAlvogen, Inc.47781-728
levothyroxine sodiumLevothyroxine sodium 125 ug/1TabletOralA-S Medication Solutions50090-4799
levothyroxine sodiumLevothyroxine sodium 125 ug/1TabletOralA-S Medication Solutions50090-7862
levothyroxine sodiumLevothyroxine sodium 175 ug/1TabletOralNorthwind Health Company, LLC51655-714
levothyroxine sodiumLevothyroxine sodium 50 ug/1TabletOralNorthwind Health Company, LLC51655-723
levothyroxine sodiumLevothyroxine sodium 150 ug/1TabletOralNorthwind Health Company, LLC51655-727
levothyroxine sodiumLevothyroxine sodium 25 ug/1TabletOralBryant Ranch Prepack63629-8711

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