Prescription drug · ANDA

Levothyroxine Sodium NDC 68180-965

Levothyroxine sodium .025 mg/1 · Tablet · Oral · Lupin Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68180-965Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0965Add 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
68180-965-0168180096501100 TABLET in 1 BOTTLE (68180-965-01)Marketed from Mar 20, 2019
68180-965-03681800965031000 TABLET in 1 BOTTLE (68180-965-03)Marketed from Mar 20, 2019
68180-965-096818009650990 TABLET in 1 BOTTLE (68180-965-09)Marketed from Mar 20, 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 — .025 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Lupin Pharmaceuticals, Inc.NDC labeler code 68180
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 68180-965_94052e3d-58b2-4f4b-8223-a47281c1a592SPL ID 94052e3d-58b2-4f4b-8223-a47281c1a592SPL set ID 18717e58-89fb-4e2f-93b6-d6ac3e988d37RxCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270UNII 9J765S329GUPC 0368180973010, 0368180971016, 0368180972013, 0368180969013, 0368180966012, 0368180970019, 0368180968016, 0368180967019, 0368180965015, 0368180976011, 0368180974017
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

N468180096501 followed by a unit qualifier and the quantity

Package 68180-0965-01. 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 68180-965

What is NDC 68180-965?
68180-965 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium .025 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc.. 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?
Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 .1 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3717
Levothyroxine SodiumLevothyroxine sodium .15 mg/1TabletOralCoupler LLC67046-0515
Levothyroxine SodiumLevothyroxine sodium .175 mg/1TabletOralCoupler LLC67046-0517
Levothyroxine SodiumLevothyroxine sodium .088 mg/1TabletOralCardinal Health 107, LLC55154-4309
Levothyroxine SodiumLevothyroxine sodium .1 mg/1TabletOralCoupler LLC67046-0569
Levothyroxine SodiumLevothyroxine sodium .125 mg/1TabletOralNuCarePharmaceuticals, Inc.68071-3692
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3956
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralA-S Medication Solutions50090-6825
Levothyroxine SodiumLevothyroxine sodium .125 mg/1TabletOralProficient Rx LP82804-246
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralA-S Medication Solutions50090-6824
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralMajor Pharmaceuticals0904-6950
Levothyroxine SodiumLevothyroxine sodium .15 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3730
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralCoupler LLC67046-0819
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralCoupler LLC67046-0801
Levothyroxine SodiumLevothyroxine sodium .112 mg/1TabletOralProficient Rx LP82804-277
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralMajor Pharmaceuticals0904-6951
Levothyroxine SodiumLevothyroxine sodium .025 mg/1TabletOralCoupler LLC67046-0828
Levothyroxine SodiumLevothyroxine sodium .075 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-5316
Levothyroxine SodiumLevothyroxine sodium .088 mg/1TabletOralMajor Pharmaceuticals0904-6952
Levothyroxine SodiumLevothyroxine sodium .05 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3750

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