Prescription drug · ANDA

Levothyroxine Sodium NDC 82804-277

Levothyroxine sodium .112 mg/1 · Tablet · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)82804-277Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0277Add 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
82804-277-308280402773030 TABLET in 1 BOTTLE (82804-277-30)Marketed from Apr 2, 2026

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 — .112 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 82804
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209713
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 82804-277_7d07e932-7372-4c17-aa53-55087107fa52SPL ID 7d07e932-7372-4c17-aa53-55087107fa52SPL set ID 7d07e932-7372-4c17-aa53-55087107fa52RxCUI 966248UNII 9J765S329GUPC 0382804277308
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

N482804027730 followed by a unit qualifier and the quantity

Package 82804-0277-30. 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)

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 82804-277

What is NDC 82804-277?
82804-277 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium .112 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 1 package NDC, 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 82804. 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 ANDA 209713

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

FDA NDC Directory listings under ANDA 209713
ProductStrengthForm · routeLabelerProduct NDC
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralMajor Pharmaceuticals0904-6949
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralMajor Pharmaceuticals0904-6950
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralMajor Pharmaceuticals0904-6951
Levothyroxine SodiumLevothyroxine sodium .088 mg/1TabletOralMajor Pharmaceuticals0904-6952
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralMajor Pharmaceuticals0904-6953
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralMajor Pharmaceuticals0904-6954
Levothyroxine SodiumLevothyroxine sodium .125 mg/1TabletOralMajor Pharmaceuticals0904-6955
Levothyroxine SodiumLevothyroxine sodium .15 mg/1TabletOralMajor Pharmaceuticals0904-6956
Levothyroxine SodiumLevothyroxine sodium .175 mg/1TabletOralMajor Pharmaceuticals0904-6957
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralA-S Medication Solutions50090-4947
Levothyroxine SodiumLevothyroxine sodium .088 mg/1TabletOralA-S Medication Solutions50090-4951
Levothyroxine SodiumLevothyroxine sodium .137 mg/1TabletOralA-S Medication Solutions50090-5792
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralA-S Medication Solutions50090-6569
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralA-S Medication Solutions50090-6572
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralA-S Medication Solutions50090-6824
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralA-S Medication Solutions50090-6825
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralA-S Medication Solutions50090-6879
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralA-S Medication Solutions50090-6880
Levothyroxine SodiumLevothyroxine sodium .15 mg/1TabletOralA-S Medication Solutions50090-6884
Levothyroxine SodiumLevothyroxine sodium .15 mg/1TabletOralA-S Medication Solutions50090-6885

Showing 20 of 40.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in