This is a package of 1,000 tablets of levothyroxine sodium 112 ug Tablet from Alvogen, Inc., marketed since May 2019 and currently FDA-listed, this package's marketing is listed to end Sep 2028; retail pharmacies pay about $0.0588 per tablet (NADAC).
NDC 47781-0654-10
🏷️ FDA NDC (as labeled)47781-654-10billing pads the product segment with a zero
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy
NDC database record
One package, one record: these facts belong to NDC 47781-654-10 alone.
Record
FDA NDC Directory package listing · Human prescription drug
Code segments
47781 labeler · 654 product · 10 package
Package marketed since
May 7, 2019
Package marketing ended
Sep 30, 2028
Sample package
No — commercial package
Billing quantity
1,000 EA per package
Barcode (UPC-A, from the NDC)
3 4778165410 8
Medicaid fills, this package
34,540 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026
🚨
Active recall for this product.
Class II · Dec 31, 2025 — Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets. (Alvogen, Inc)· FDA recall D-0259-2026
Lots / codes: Lot # MHA21825, Exp Date: December 31, 2027 · reported Jan 21, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Levothyroxine Sodium (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.)· FDA recall D-0776-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.)· FDA recall D-0781-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.)· FDA recall D-0775-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.)· FDA recall D-0782-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.)· FDA recall D-0786-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.)· FDA recall D-0780-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Feb 6, 2023 · Terminated — Sub-Potent Drug: Out of specification for assay at the 24 month interval. (Alvogen, Inc)· FDA recall D-0353-2023
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)47781-654-10
Product NDC47781-654
11-digit billing NDC47781065410
NCPDP billing unitEA — each (per item)
Application #NDA021116
SPL Set ID3b8c38aa-ac99-1c0d-42f3-4fe8881125dc
Established class (EPC)l-Thyroxine
Chemical classThyroxine
DEA scheduleNon-controlled
Marketing categoryNDA
Marketing statusOn market
FDA listing statusListed (active directory)
Marketing start2019-05-07
Marketing end2028-09-30
RouteORAL
Dosage formTABLET
SubstanceLEVOTHYROXINE SODIUM
TE code (Orange Book)AB1,AB2,AB3,AB4 · RLD · RS
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GCN Seq No006652
GCN26320
HICL code002849
Ingredient (HICL)Levothyroxine Sodium
HIC1 codeP
Therapeutic class — broad (HIC1)Endocrine System
HIC2 codeP3
Therapeutic class — intermediate (HIC2)Drugs Affecting Thyroid Function
HIC3 codeP3A
Therapeutic class — specific (HIC3)Thyroid Hormones
AHFS code68:36.04.00
AHFS classThyroid Agents
FDB label nameLEVOTHYROXINE 112 MCG TABLET
FDB brand nameLevothyroxine Sodium
Legend statusF — Federal legend — prescription drug or device
Quick answers
GSN (GCN sequence number):006652
GCN:26320
HICL (First Databank):002849
AHFS class code:68:36.04.00
Why two NDCs?
The FDA registers this code as 47781-654-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 47781-0654-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
Label name LEVOTHYROXINE 112 MCG TABLETIngredient Levothyroxine Sodium
📖 What it is MedlinePlus · NLM
Levothyroxine is used to treat hypothyroidism (condition where the thyroid gland does not produce enough thyroid hormone). It is also used with surgery and radioactive iodine therapy to treat thyroid cancer. Levothyroxine is in a class of medications called hormones. It works by replacing thyroid hormone that is normally produced by the body. Without thyroid hormone, your body cannot function properly, which may result in poor growth, slow speech, lack of energy, excessive tiredness, constipation, weight gain, hair loss, dry, thick skin, increased sensitivity to cold, joint and muscle pain, he...
It replaces thyroid hormone when your thyroid doesn’t make enough, a condition called hypothyroidism. Oral forms are also used with surgery and radioiodine for certain thyroid canc...
Oral forms are usually taken once a day on an empty stomach, about 15 to 60 minutes before breakfast, depending on the product. Keep calcium, iron and antacids at least 4 hours awa...
Full effect may take 4 to 6 weeks. Your doctor will check TSH and/or T4 blood tests to adjust your dose.
No. It doesn’t cause weight loss at normal doses if your thyroid is normal. Larger doses can be seriously toxic.
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
Price system
Per ea
Per package
Retail pharmacies payNADAC · weekly
$0.059
$58.80 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo
$0.2022
$202.20 / 1000 tablets
Medicare drug plans payPart D · Q2 2026
$0.1283
$128.30 / 1000 tablets
NADAC price history (per ea) — tap or hover for the price & month
▼ Down 67% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
You're viewing the largest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0588 NADAC).
This pack accounts for about 37% of this product's recent Medicaid fills; most go to the 90 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in this package?
This is a 1,000-count package — 1000 tablet in 1 bottle.
How does this package differ from NDC 47781-0654-90?
Both are levothyroxine sodium 112 ug Tablet — the drug itself is identical. This page's package is the 1,000-count one, while NDC 47781-0654-90 is the 90 tablets package.
What NDC number is used to bill for this package of levothyroxine sodium 112 ug Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
Inactive ingredients, also called excipients, are components of the drug product
other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors,
or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
34.5K
Units reimbursed last 4 qtrs
2.1M
Gross reimbursed last 4 qtrs
$426K
Avg / prescription
$12.33
Avg / unit
$0.2022
Latest quarter Q1 2026
9.9KRx
Medicaid pays / ea
$0.2022
gross reimbursed
vs
NADAC / ea
$0.0588
acquisition cost
=
Spread
+$0.1434
+244% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
38% FFS62% MCO
Fee-for-service · 13,232 Rx Managed care · 21,308 Rx
State Medicaid map
Units reimbursed · per 100k residents
11.72,578
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1Indiana2,578 /100k
2Pennsylvania2,507 /100k
3New York2,069 /100k
4West Virginia1,955 /100k
5Ohio1,622 /100k
6Maryland1,463 /100k
7New Jersey1,371 /100k
8Delaware956 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 93,464 Rx · 5,190,707 units · $832,544 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Levothyroxine Sodium — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Levothyroxine Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$118.86M
Claims incl. refills
10.9M
Beneficiaries
7.8M
Spend / beneficiary
$15.20
Spend / claim
$10.88
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.