Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy
🆔 Identity & classification
FDA NDC (as labeled)0480-3296-56
Product NDC0480-3296
11-digit billing NDC00480329656
NCPDP billing unitEA — each (per item)
SPL Set ID1164ca5c-4e20-4373-a381-f8f66dabd035
DEA scheduleCIV
Marketing categoryDRUG FOR FURTHER PROCESSING
Marketing statusOn market
FDA listing statusListed (active directory)
Marketing start2024-11-06
Dosage formCAPSULE, EXTENDED RELEASE
SubstancePHENTERMINE HYDROCHLORIDE; TOPIRAMATE
GCN Seq No069618
GCN32744
HICL code039347
Ingredient (HICL)Phentermine/Topiramate
HIC1 codeJ
Therapeutic class — broad (HIC1)Autonomic Nervous System
HIC2 codeJ8
Therapeutic class — intermediate (HIC2)Anti-Obesity - Anorexics
HIC3 codeJ8A
Therapeutic class — specific (HIC3)Anti-Obesity - Anorexic Agents
AHFS code28:20.08.00
AHFS classAnorexigenic Agents
FDB label namePHENTERMINE-TOPIR ER 7.5-46 MG
FDB brand namePhentermine-Topiramate Er
Legend statusF — Federal legend — prescription drug or device
Why two NDCs?
The FDA registers this code as 0480-3296-56 — a 4-4-2 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 labeler segment → 00480-3296-56. 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.
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.
🩺 Clinical
Label name PHENTERMINE-TOPIR ER 7.5-46 MGIngredient Phentermine/Topiramate
📗 Our plain-language guide HelloPharmacist
It's more than a simple appetite suppressant. Phentermine and topiramate combines two different drugs: phentermine reduces your appetite by triggering certain brain chemicals, and...
What exactly does this medication do — is it just a diet pill?
Take it once every morning — timing really does matter here. Taking it in the evening can interfere with your sleep. The good news is you can take it with or without food, so don't...
When should I take it, and does it matter if I eat first?
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.
💬 Questions about Phentermine and topiramate?
Ask a licensed pharmacist directly — free, answered by our team.
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.
Inactive ingredient FAQ
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.
💲 Pricing
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
$3.292
$98.76 / 30 capsules
Medicaid paysCMS SDUD · 12 mo
$4.92
$147.65 / 30 capsules
Medicare drug plans payPart D · quarterly
No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
▼ Down 10% over the last 9 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.
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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.
⏳ Availability & generic status
🏛️
2024
On the market since
Nov 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available
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.
🗺️ 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 00480-3296-56, 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.
📅 Q2 2025 – Q4 2025 · 3 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
227
Units reimbursed last 4 qtrs
6.9K
Gross reimbursed last 4 qtrs
$34K
Avg / prescription
$149.92
Avg / unit
$4.9215
Latest quarter Q4 2025
122Rx
Medicaid pays / ea
$4.9215
gross reimbursed
vs
NADAC / ea
$3.2920
acquisition cost
=
Spread
+$1.6295
+49% 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 ⓘ
73% FFS27% MCO
Fee-for-service · 166 Rx Managed care · 61 Rx
State Medicaid map
Units reimbursed · per 100k residents
3.622.4
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
1Oregon22.4 /100k
2California13.1 /100k
3North Carolina4.7 /100k
4Michigan3.6 /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): 434 Rx · 13,170 units · $57,943 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Phentermine and topiramate — the ingredient across all brands.
Top reported reactions
Headache362
Paraesthesia323
Insomnia277
Dry Mouth273
Dizziness262
Weight Increased262
Feeling Abnormal218
Reporter sex
Serious outcomes
Disabling52
Life-threatening27
Death16
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
14719 CAPSULE, EXTENDED RELEASE in 1 CONTAINER (0480-3296-99)
—
—
—
Active
00480-3296-56 You're viewing this
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3296-56)
$3.29 / ea
$98.76
2025-05-07
Active
You're viewing the smallest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00480-3296-56?
NDC 00480-3296-56 is a 30-count package — 30 capsule, extended release in 1 bottle.
What is the difference between NDC 00480-3296-56 and NDC 00480-3296-99?
Both are Phentermine and topiramate 7.5 mg; 46 mg Capsule, Extended Release — the drug itself is identical. NDC 00480-3296-56 is the 30-count package, while NDC 00480-3296-99 is the 14719 capsules package.
What NDC number is used to bill for this package of Phentermine and topiramate 7.5 mg; 46 mg Capsule, Extended Release?
Bill NDC 00480-3296-56 — the 11-digit billing format is 00480329656. 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 NDC listing & data coverage
Listed for further processing / repackaging
What "drug for further processing" means
FDA lists this package under the "drug for further processing" marketing category: Teva Pharmaceuticals, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes)
✓ Available
Labeler
✓ Available
Product & package description
✓ Available
Marketing category & status
✓ Available
Active ingredient / dosage form / route
✓ Available
FDA label (SPL via DailyMed)
✓ Available
Package photos
— Not published for this NDCNo photo available yet for this listing.
Inactive ingredients (structured)
— Not published for this NDCThe labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)
✓ Available
Orange Book / therapeutic-equivalence data
— Not published for this NDCApplies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk
— Not published for this NDCMost self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)
✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0480-3296-56, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00480-3296-56, written without dashes as 00480329656. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00480-3296-56, the first segment (00480) is the labeler code FDA assigned to Teva Pharmaceuticals, Inc.; the middle segment (3296) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (56) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Teva Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 14719 capsules (00480-3296-99). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Teva Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 Full FDA label FDA SPL
The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
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.