Prescription drug · NDA AUTHORIZED GENERIC

Levothyroxine Sodium NDC 63629-2091

Levothyroxine sodium 200 ug/1 · Tablet · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2091Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2091Add 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
63629-2091-1636292091011000 TABLET in 1 BOTTLE (63629-2091-1)Marketed from Feb 9, 2021

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 — 200 ug/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021342
Marketing start
Listing expires
Other FDA classes
Thyroxine (Chemical structure)
Identifiers
Product ID 63629-2091_774c0eba-3b00-4394-9d2e-11d849ba9300SPL ID 774c0eba-3b00-4394-9d2e-11d849ba9300SPL set ID 8ac112c3-1e06-4fdb-a7af-2ee988de5b15RxCUI 892251UNII 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

N463629209101 followed by a unit qualifier and the quantity

Package 63629-2091-01. 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 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 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 patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-2091

What is NDC 63629-2091?
63629-2091 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium 200 ug/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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 021342

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

FDA NDC Directory listings under NDA 021342
ProductStrengthForm · routeLabelerProduct NDC
Levothyroxine SodiumLevothyroxine sodium 137 ug/1TabletOralLannett Company, Inc0527-3287
Levothyroxine SodiumLevothyroxine sodium 137 ug/1TabletOralNorthwind Health Company, LLC51655-128
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralNuCare Pharmaceuticals,Inc.68071-2278
Levothyroxine SodiumLevothyroxine sodium 125 ug/1TabletOralBryant Ranch Prepack71335-1499
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralLannett Company, Inc0527-3284
Levothyroxine SodiumLevothyroxine sodium 112 ug/1TabletOralLannett Company, Inc0527-3285
Levothyroxine SodiumLevothyroxine sodium 125 ug/1TabletOralLannett Company, Inc0527-3286
Levothyroxine SodiumLevothyroxine sodium 150 ug/1TabletOralLannett Company, Inc0527-3288
Levothyroxine SodiumLevothyroxine sodium 175 ug/1TabletOralLannett Company, Inc0527-3289
Levothyroxine SodiumLevothyroxine sodium 88 ug/1TabletOralNorthwind Health Company, LLC51655-728
Levothyroxine SodiumLevothyroxine sodium 100 ug/1TabletOralA-S Medication Solutions50090-5654
Levothyroxine SodiumLevothyroxine sodium 200 ug/1TabletOralBryant Ranch Prepack71335-1940
Levothyroxine SodiumLevothyroxine sodium 200 ug/1TabletOralLannett Company, Inc0527-3290
Levothyroxine SodiumLevothyroxine sodium 175 ug/1TabletOralBryant Ranch Prepack72162-1093
Levothyroxine SodiumLevothyroxine sodium 88 ug/1TabletOralBryant Ranch Prepack72162-1090
Levothyroxine SodiumLevothyroxine sodium 200 ug/1TabletOralBryant Ranch Prepack71335-2994
Levothyroxine SodiumLevothyroxine sodium 112 ug/1TabletOralBryant Ranch Prepack72162-1091
Levothyroxine SodiumLevothyroxine sodium 137 ug/1TabletOralBryant Ranch Prepack72162-1092
Levothyroxine SodiumLevothyroxine sodium 112 ug/1TabletOralBryant Ranch Prepack71335-1955
Levothyroxine SodiumLevothyroxine sodium 125 ug/1TabletOralCoupler LLC67046-1612

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