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Metformin Hydrochloride 850 mg Tablet, 100-count — NDC 70010-064-01 (Billing 70010-0064-01)

by Granules Pharmaceuticals Inc · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Metformin Hydrochloride 850 mg Tablet from Granules Pharmaceuticals Inc, marketed since Jun 2019 and currently FDA-listed; retail pharmacies pay about $0.0240 per tablet (NADAC).

NDC 70010-0064-01
🏷️ FDA NDC (as labeled) 70010-064-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0240 NADAC Per package$2.40 / 100 tablets Pack sizes7 compare ↓
Also priced by: Medicaid pays $0.1183/unit · Part D plans $0.0671/unit — full pricing hub ↓
Product page 70010-0064-05 Also comes in: 60 tablets 70010-064-06 90 tablets 70010-064-09 500 tablets 70010-064-05 1000 tablets 70010-064-10 1000 tablets 70010-064-99 32857 tablets 70010-064-16
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 70010-064-01 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
70010 labeler · 064 product · 01 package
Listing certified through
Dec 31, 2027
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 7001006401 0
Medicaid fills, this package
11,600 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Metformin Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0328-2025
Class II · Feb 25, 2025 — Presence of Foreign Tablets/Capsules. (A-S Medication Solutions LLC) · FDA recall D-0292-2025
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) 70010-064-01
Product NDC 70010-064
11-digit billing NDC 70010006401
NCPDP billing unit EA — each (per item)
SPL Set ID 4f7e7705-8e64-55e6-e063-6394a90a19d9
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-07
Dosage form TABLET
Substance METFORMIN HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 27250050000340
GPI class metFORMIN HCl
GCN Seq No 016441
GCN 10811
HICL code 004763
Ingredient (HICL) Metformin Hcl
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4L
Therapeutic class — specific (HIC3) Antihyperglycemic, Biguanide Type
AHFS code 68:20.04.00
AHFS class Biguanides
FDB label name METFORMIN HCL 850 MG TABLET
FDB brand name Metformin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016441
  • GCN: 10811
  • GPI-14 (Medi-Span): 27250050000340
  • HICL (First Databank): 004763
  • AHFS class code: 68:20.04.00
Why two NDCs? The FDA registers this code as 70010-064-01 — 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 → 70010-0064-01. 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

Label name METFORMIN HCL 850 MG TABLET Ingredient Metformin Hcl
📗 Our plain-language guide HelloPharmacist
  • Metformin works in three ways: it lowers the amount of sugar your liver dumps into your bloodstream, slows how much sugar your gut absorbs from food, and helps your body respond to...
  • What exactly is metformin doing for my diabetes?
  • Yes, this is very common — diarrhea, nausea, and stomach discomfort are the most frequently reported side effects, and they're often worst when you first start or when your dose go...
  • My stomach has been a mess since I started metformin. Is that normal? Will it get better?
📖 Read our full Metformin guide →
4
Nutrient depletion considerations

Metformin Hydrochloride may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Metformin Hydrochloride nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 eaPer package
Retail pharmacies payNADAC · weekly $0.024 $2.40 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1183 $11.83 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.0671 $6.71 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.029 $0.023
▼ Down 14% 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
70010-0064-01 You're viewing this 100 TABLET in 1 BOTTLE $0.0240 / ea $2.40 2019-06-26 — Active
70010-0064-05 70010-064-05 Main listing 500 TABLET in 1 BOTTLE $0.0240 / ea $11.99 2019-06-26 — Active
70010-0064-06 70010-064-06 60 TABLET in 1 BOTTLE — — 2019-06-26 — Active
70010-0064-09 70010-064-09 90 TABLET in 1 BOTTLE $0.0240 / ea $2.16 2019-06-26 — Active
70010-0064-10 70010-064-10 1000 TABLET in 1 BOTTLE $0.0239 / ea $23.88 2019-06-26 — Active
70010-0064-99 70010-064-99 1000 TABLET in 1 BOTTLE $0.0240 / ea $23.98 2023-08-09 — Active
70010-0064-16 70010-064-16 32857 TABLET in 1 DRUM — — — — Active

This pack effectively ties for the lowest per-ea cost of the 5 priced pack sizes ($0.0240 NADAC).

This pack accounts for about 10% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 70010-0064-06?
Both are Metformin Hydrochloride 850 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 70010-0064-06 is the 60 tablets package.
What NDC number is used to bill for this package of Metformin Hydrochloride 850 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.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metformin Hydrochloride 850 mg 00378-7186-05 Mylan 500 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 00904-7163-61 Major 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 23155-0842-01 Heritage 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 42385-0948-01 Laurus 100 tablets $0.024 AB Availability likely —
Metformin HCl 850 mg 49483-0621-01 TIME 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 59651-0855-01 Aurobindo 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 60687-0143-01 American 1 tablet $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 65862-0009-01 Aurobindo 100 tablets $0.024 AB Availability likely —
Metformin HCl 850 mg 67877-0562-01 Ascend 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 67877-0931-01 Ascend 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 68094-0580-60 Precision 500 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 68382-0759-01 Zydus 100 tablets $0.024 AB Availability likely —
Metformin hydrochloride 850 mg 68645-0583-59 Legacy 60 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 69367-0181-01 Westminster 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 69367-0382-01 Westminster 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mgthis 70010-0064-01 Granules 100 tablets $0.024 — Availability likely —
Metformin Hydrochloride 850 mg 83301-0009-01 Mullan 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 71093-0133-04 ACI 100 tablets $0.025 AB Availability likely +4%
Metformin Hydrochloride 850 mg 42806-0314-01 Epic 100 tablets $0.027 AB FDA listed +14%
Metformin Hydrochloride 850 mg 00615-8577-39 NCS 30 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 24658-0791-05 PuraCap 500 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 25000-0131-03 MARKSANS 30 tablets — AB FDA listed —
Metformin hydrochloride 850 mg 33342-0142-10 Macleods 90 tablets — — FDA listed —
Metformin HCl 850 mg 50090-3050-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 50090-6753-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 50090-6754-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 50090-7106-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 50090-7107-00 A-S 90 tablets — AB FDA listed —
Metformin HCl 850 mg 50090-7465-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 50228-0106-00 ScieGen 4200 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 53746-0219-01 Amneal 100 tablets — — FDA listed —
Metformin Hydrochloride 850 mg 60429-0112-01 Golden 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 62135-0683-05 Chartwell 500 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 62207-0441-43 Granules 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 65841-0810-01 Zydus 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 67046-0804-03 Coupler 30 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 67877-0218-01 Ascend 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68071-3495-08 NuCare 180 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68071-3531-01 NuCare 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68071-3575-08 NuCare 180 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68071-3833-08 NuCare 180 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68788-8528-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68788-8603-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68788-8756-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 70518-3084-00 REMEDYREPACK 30 tablets — AB Discontinued —
Metformin HCl 850 mg 70518-4479-00 REMEDYREPACK 90 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 70882-0125-30 Cambridge 30 tablets — AB Discontinued —
Metformin HCl 850 mg 71205-0567-00 Proficient 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71205-0883-00 Proficient 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71335-1785-01 Bryant 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71335-1835-01 Bryant 60 tablets — AB FDA listed —
Metformin HCl 850 mg 71335-1983-01 Bryant 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71335-2245-01 Bryant 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71335-2593-01 Bryant 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71610-0918-60 Aphena 90 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71610-0923-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71709-0111-06 Metcure 500 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 72189-0221-90 direct 90 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 72789-0409-90 PD-Rx 90 tablets — AB FDA listed —
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

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 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.

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 Metformin 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.

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.

Manufacturer & labeler

LabelerGranules Pharmaceuticals Inc
Labeler code70010
First marketedJun 2019
Product typeDrug For Further Processing
Portfolio11 products on file

More NDCs from Granules Pharmaceuticals Inc labeler code 70010

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 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.
📄 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 ↗

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
11.6K
Units reimbursed last 4 qtrs
1M
Gross reimbursed last 4 qtrs
$119.8K
Avg / prescription
$10.33
Avg / unit
$0.1183
Latest quarter Q1 2026
2.4KRx
Medicaid pays / ea
$0.1183
gross reimbursed
vs
NADAC / ea
$0.0240
acquisition cost
=
Spread
+$0.0943
+393% 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 ⓘ
57% FFS 43% MCO
Fee-for-service · 6,605 Rx Managed care · 4,995 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 13,179 units · 169 per 100k residents WA Idaho: 4,622 units · 235 per 100k residents ID Montana: 308 units · 27.2 per 100k residents MT North Dakota: 660 units · 84.3 per 100k residents ND Minnesota: 7,365 units · 128 per 100k residents MN Wisconsin: 14,147 units · 239 per 100k residents WI Michigan: 40,414 units · 403 per 100k residents MI New York: 98,381 units · 503 per 100k residents NY Vermont: 1,638 units · 253 per 100k residents VT New Hampshire: no data reported NH Oregon: 11,301 units · 267 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 3,310 units · 360 per 100k residents SD Iowa: 5,790 units · 181 per 100k residents IA Illinois: 15,493 units · 123 per 100k residents IL Indiana: 7,742 units · 113 per 100k residents IN Ohio: 20,435 units · 173 per 100k residents OH Pennsylvania: 33,049 units · 255 per 100k residents PA New Jersey: 56,481 units · 608 per 100k residents NJ Massachusetts: 2,996 units · 42.8 per 100k residents MA California: 443,001 units · 1,137 per 100k residents CA Utah: 5,760 units · 169 per 100k residents UT Colorado: 3,790 units · 64.5 per 100k residents CO Nebraska: 3,090 units · 156 per 100k residents NE Missouri: 20,116 units · 325 per 100k residents MO Kentucky: 21,025 units · 465 per 100k residents KY West Virginia: 10,568 units · 597 per 100k residents WV Virginia: 8,457 units · 97.0 per 100k residents VA Maryland: 12,932 units · 209 per 100k residents MD Connecticut: 6,827 units · 189 per 100k residents CT Rhode Island: no data reported RI Arizona: 4,890 units · 65.8 per 100k residents AZ New Mexico: 8,592 units · 406 per 100k residents NM Kansas: 2,972 units · 101 per 100k residents KS Arkansas: 4,618 units · 151 per 100k residents AR Tennessee: 9,797 units · 137 per 100k residents TN North Carolina: 15,508 units · 143 per 100k residents NC South Carolina: 5,186 units · 96.5 per 100k residents SC Delaware: 2,250 units · 218 per 100k residents DE Oklahoma: 5,193 units · 128 per 100k residents OK Louisiana: 6,800 units · 149 per 100k residents LA Mississippi: 1,262 units · 42.9 per 100k residents MS Alabama: 3,125 units · 61.2 per 100k residents AL Georgia: 16,322 units · 148 per 100k residents GA D.C.: 3,790 units · 558 per 100k residents DC Hawaii: 3,440 units · 240 per 100k residents HI Texas: 16,839 units · 55.2 per 100k residents TX Florida: 19,392 units · 85.8 per 100k residents FL
Units reimbursed · per 100k residents
27.21,137
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
🏆 Top states by units · per 100k residents
1 California 1,137 /100k
2 New Jersey 608 /100k
3 West Virginia 597 /100k
4 D.C. 558 /100k
5 New York 503 /100k
6 Kentucky 465 /100k
7 New Mexico 406 /100k
8 Michigan 403 /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.
500 tablets70010-0064-05 78,643 Rx · $808,661
1000 tablets70010-0064-99 22,258 Rx · $217,050
100 tablets this page70010-0064-01 11,600 Rx · $119,814
1000 tablets70010-0064-10 963 Rx · $11,052
90 tablets70010-0064-09 701 Rx · $7,802
60 tablets70010-0064-06 No Medicaid data
32857 tablets70010-0064-16 No Medicaid data
Drug total (last 4 qtrs): 114,165 Rx · 9,756,162 units · $1,164,378 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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: Granules 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 NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The 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 NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) ✓ 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 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 Granules 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 6 other package presentations of this same product, including 60 tablets (70010-0064-06), 90 tablets (70010-0064-09), 500 tablets (70010-0064-05). 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?
Granules 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.
← 70010-0063-01 · Granules 70010-0065-01 · Granules →
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.