Home › NDC Lookup › Ingredients › Cyclobenzaprine Hydrochloride › 00615-8665-05
Cyclobenzaprine Hydrochloride 10 mg Tablet, 15-count — NDC 00615-8665-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cyclobenzaprine Hydrochloride 10 mg Tablet, 15-count — NDC 0615-8665-05 (Billing 00615-8665-05)

by NCS HealthCare of KY, LLC dba Vangard Labs · 15 TABLET in 1 BLISTER PACK

This is a package of 15 tablets of Cyclobenzaprine Hydrochloride 10 mg Tablet from NCS HealthCare of KY, LLC dba Vangard Labs, marketed since Feb 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00615-8665-05
🏷️ FDA NDC (as labeled) 0615-8665-05 billing pads the labeler segment with a zero
This package
Contains15-count Pack sizes2 compare ↓
Main listing for product 0615-8665 · Also comes in: 30 tablets 0615-8665-39
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ 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
📋 All sources & update times →

This page is curated, coded, and maintained by

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 0615-8665-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0615 labeler · 8665 product · 05 package
Package marketed since
Sep 8, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0615866505 5
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Cyclobenzaprine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Aug 27, 2025 — Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). (Unichem Pharmaceuticals USA Inc.) · FDA recall D-0655-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0615-8665-05
Product NDC 0615-8665
11-digit billing NDC 00615866505
Application # ANDA218936
SPL Set ID c8566e45-6159-4877-aaa6-1cf968ccb450
Established class (EPC) Muscle Relaxant
Physiologic effect Centrally-mediated Muscle Relaxation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-19
Route ORAL
Dosage form TABLET
Substance CYCLOBENZAPRINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0615-8665-05 — 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 → 00615-8665-05. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Cyclobenzaprine tablets and extended-release capsules ease muscle spasm from recent, painful muscle or joint problems. You use them with rest and physical therapy. Tonmya, a differ...
  • For muscle spasm, it's meant for short-term use only, about two or three weeks. Spasms usually improve in that time, and there's no good evidence it works longer.
  • Dry mouth, drowsiness, dizziness, tiredness, constipation and nausea are the most common. Be careful driving until you know how it affects you. Call your doctor if side effects bot...
  • Alcohol and other sedating medicines can make it stronger, so avoid mixing them. Tell me about any antidepressants, tramadol or other related medicines, because of the risk of sero...
📖 Read our full Cyclobenzaprine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
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.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00615-8665-05 You're viewing this Main listing 15 TABLET in 1 BLISTER PACK 2026-09-08 — Active
00615-8665-39 0615-8665-39 30 TABLET in 1 BLISTER PACK 2026-09-08 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 15-count package — 15 tablet in 1 blister pack.
How does this package differ from NDC 00615-8665-39?
Both are Cyclobenzaprine Hydrochloride 10 mg Tablet — the drug itself is identical. This page's package is the 15-count one, while NDC 00615-8665-39 is the 30 tablets package.
What NDC number is used to bill for this package of Cyclobenzaprine Hydrochloride 10 mg 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cyclobenzaprine Hydrochloride 10 mg 16571-0783-01 Rising 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 52817-0332-00 TruPharma 1000 tablets $0.017 AB Availability likely —
Cyclobenzaprine hydrochloride 10 mg 29300-0415-01 Unichem 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 00093-3422-01 Teva 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 72603-0312-01 NORTHSTAR 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 70512-0872-10 SOLA 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 64980-0657-01 Rising 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 72888-0014-00 Advagen 1000 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 59746-0177-06 Jubilant 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 00904-7401-61 Major 1 tablet $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 10702-0007-01 KVK-TECH, 100 tablets $0.022 AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 62332-0647-31 Alembic 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63187-0157-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 65862-0191-01 Aurobindo 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71205-0201-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0016-30 Aphena 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0428-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0271-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4730-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 53746-0541-01 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-1209-01 Bryant 1000 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 71205-0065-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-1266-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 71335-1962-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0033-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0599-02 Asclemed 2 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85509-1014-03 PHOENIX 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4722-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 67296-1441-01 Redpharm 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 55154-0190-00 Cardinal 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67046-1566-03 Coupler 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2492-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72189-0080-07 DIRECT 7 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 43547-0400-01 Solco 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 45865-0244-14 Medsource 14 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-1893-03 Redpharm 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-4935-06 NuCare 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-8474-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 69306-0872-03 Doc 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2110-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85766-0003-00 Sportpharm 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4727-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5713-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-2659-03 NuCare 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 70518-3764-00 REMEDYREPACK 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2666-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0011-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0830-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0019-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0498-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 42291-0154-10 AvKARE 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0539-20 Northwind 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3561-04 NuCare 4 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 76420-0841-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0547-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85766-0041-00 Sportpharm 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 87441-0010-01 Unit 30 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5712-00 A-S 3 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-1211-01 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-4951-02 NuCare 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 70518-3474-00 REMEDYREPACK 1 tablet — AB Discontinued —
Cyclobenzaprine hydrochloride 10 mg 70518-3702-00 REMEDYREPACK 60 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 71335-2678-01 Bryant 5 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72162-1359-00 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5711-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5772-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-9297-01 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67046-1645-03 Coupler 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-2084-01 Redpharm 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3404-03 NuCare 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-6864-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0592-20 Northwind 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3462-02 NuCare 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3981-06 NuCare 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 70518-3415-00 REMEDYREPACK 30 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 71335-2686-01 Bryant 5 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4729-01 A-S 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3627-05 NuCare 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0156-15 PD-Rx 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 82461-0716-90 Medcore 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 82804-0259-30 Proficient 30 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 85509-1415-03 PHOENIX 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 60760-0767-04 ST. 4 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-1210-01 Bryant 500 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 65162-0541-10 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3973-07 NuCare 14 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-8167-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 68788-8637-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0907-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72189-0545-15 Direct_Rx 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0036-01 PD-Rx 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0046-03 PD-Rx 3 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85534-0086-00 HAWAII 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 70518-4692-00 REMEDYREPACK 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-4154-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-2306-02 Redpharm 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mgthis 00615-8665-05 NCS 15 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 85766-0274-01 Sportpharm 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

What it looks like

Color yellow
ShapeRound
ImprintC10;Gr
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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.

🧪 Avoiding an ingredient? See Cyclobenzaprine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

Manufacturer & labeler

LabelerNCS HealthCare of KY, LLC dba Vangard Labs
Application holderRISING PHARMA HOLDINGS INC
FDA applicationANDA218936 (ANDA)
Labeler code00615
First marketedFeb 2025
Product typeHuman Prescription Drug
Portfolio326 products on file

More NDCs from NCS HealthCare of KY, LLC dba Vangard Labs labeler code 00615

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.

Full prescribing information FDA SPL

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 NCS HealthCare of KY, LLC dba Vangard Labs. 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 30 tablets (00615-8665-39). 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?
NCS HealthCare of KY, LLC dba Vangard Labs 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.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 00615-8664-39 · NCS 00641-0367-25 · Hikma →
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.