NDC codes

FDA NDC Directory
Product NDC (as listed)16729-454Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16729-0454Add 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
16729-454-151672904541590 TABLET in 1 BOTTLE (16729-454-15)Marketed from Nov 25, 2020
16729-454-17167290454171000 TABLET in 1 BOTTLE (16729-454-17)Marketed from Dec 3, 2020

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 — 137 ug/1
Dosage form
Tablet
Route
Oral
Labeler
Accord Healthcare Inc.NDC labeler code 16729
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212399
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 16729-454_415fc774-31a5-124f-e063-6294a90a0e46SPL ID 415fc774-31a5-124f-e063-6294a90a0e46SPL set ID a6233381-3043-4e9a-aaa6-a6b105e5142bRxCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270UNII 9J765S329GUPC 0316729447157, 0316729449151, 0316729452151, 0316729454155, 0316729453158, 0316729448154, 0316729451154, 0316729457156, 0316729450157, 0316729456159, 0316729458153, 0316729455152
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

N416729045415 followed by a unit qualifier and the quantity

Package 16729-0454-15. 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 16729-454

What is NDC 16729-454?
16729-454 is the product NDC for Levothyroxine sodium, Levothyroxine sodium 137 ug/1 tablet, listed with the FDA by Accord Healthcare 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?
Accord Healthcare Inc., NDC labeler code 16729. 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 ANDA 212399

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

FDA NDC Directory listings under ANDA 212399
ProductStrengthForm · routeLabelerProduct NDC
Levothyroxine sodiumLevothyroxine sodium 100 ug/1TabletOralPreferred Pharmaceuticals Inc.68788-7929
Levothyroxine sodiumLevothyroxine sodium 125 ug/1TabletOralA-S Medication Solutions50090-6981
Levothyroxine sodiumLevothyroxine sodium 50 ug/1TabletOralPreferred Pharmaceuticals Inc.68788-7911
Levothyroxine SodiumLevothyroxine sodium 112 ug/1TabletOralDirect_Rx72189-605
Levothyroxine sodiumLevothyroxine sodium 25 ug/1TabletOralA-S Medication Solutions50090-7860
Levothyroxine SodiumLevothyroxine sodium 200 ug/1TabletOralDirect Rx72189-346
Levothyroxine sodiumLevothyroxine sodium 25 ug/1TabletOralREMEDYREPACK INC.70518-4400
Levothyroxine sodiumLevothyroxine sodium 137 ug/1TabletOralREMEDYREPACK INC.70518-4399
Levothyroxine sodiumLevothyroxine sodium 100 ug/1TabletOralREMEDYREPACK INC.70518-4401
Levothyroxine sodiumLevothyroxine sodium 125 ug/1TabletOralREMEDYREPACK INC.70518-4402
Levothyroxine sodiumLevothyroxine sodium 150 ug/1TabletOralREMEDYREPACK INC.70518-4403
Levothyroxine sodiumLevothyroxine sodium 175 ug/1TabletOralA-S Medication Solutions50090-6634
Levothyroxine sodiumLevothyroxine sodium 25 ug/1TabletOralProficient Rx LP82804-168
Levothyroxine sodiumLevothyroxine sodium 112 ug/1TabletOralBryant Ranch Prepack71335-2007
Levothyroxine sodiumLevothyroxine sodium 137 ug/1TabletOralRedPharm Drug, Inc67296-1908
Levothyroxine sodiumLevothyroxine sodium 50 ug/1TabletOralA-S Medication Solutions50090-6660
Levothyroxine SodiumLevothyroxine sodium 88 ug/1TabletOralDirect_rx72189-604
Levothyroxine sodiumLevothyroxine sodium 88 ug/1TabletOralA-S Medication Solutions50090-7871
Levothyroxine sodiumLevothyroxine sodium 125 ug/1TabletOralPreferred Pharmaceuticals Inc.68788-7945
Levothyroxine sodiumLevothyroxine sodium 88 ug/1TabletOralPreferred Pharmaceuticals Inc.68788-7943

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