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mesalamine 1.2 g Tablet, Delayed Release, 120-count — NDC 16714-830-01 (Billing 16714-0830-01)

by Northstar Rx LLC. · 120 TABLET, DELAYED RELEASE in 1 BOTTLE

This is a package of 120 tablets of mesalamine 1.2 g Tablet, Delayed Release from Northstar Rx LLC., no longer marketed, no longer in the FDA NDC Directory; retail pharmacies pay about $0.8559 per tablet (NADAC). It is this product's only package size.

NDC 16714-0830-01
🏷️ FDA NDC (as labeled) 16714-830-01 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Mar 13, 2024 · 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 16714-830-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
16714 labeler · 830 product · 01 package
Billing quantity
120 EA per package
Barcode (UPC-A, from the NDC)
3 1671483001 8
Medicaid fills, this package
2,080 prescriptions in the last four reported quarters
FDA record last changed
Mar 13, 2024
⚠️
Other active recalls for Mesalamine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 5, 2024 — Failed Dissolution Specifications: Out of specification for dissolution. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0350-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jan 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 16714-830-01
Product NDC 16714-830
11-digit billing NDC 16714083001
NCPDP billing unit EA — each (per item)
Application # ANDA091640
Chemical class Aminosalicylate [EPC], Aminosalicylic Acids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jan 2026)
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance MESALAMINE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 062058
GCN 97842
HICL code 001848
Ingredient (HICL) Mesalamine
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6F
Therapeutic class — specific (HIC3) Drug Tx-Chronic Inflam. Colon Dx,5-Aminosalicylat
AHFS code 56:36.00.00
AHFS class Anti-Inflammatory Agents (Gi Drugs)
FDB label name MESALAMINE DR 1.2 GM TABLET
FDB brand name Mesalamine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 062058
  • GCN: 97842
  • HICL (First Databank): 001848
  • AHFS class code: 56:36.00.00
Why two NDCs? The FDA registers this code as 16714-830-01 — 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 → 16714-0830-01. 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 MESALAMINE DR 1.2 GM TABLET Ingredient Mesalamine
📗 Our plain-language guide HelloPharmacist
  • It treats ulcerative colitis and, in rectal forms, inflammation in the lower bowel such as proctitis. Some products are for flares, some for keeping remission, and some for both. Y...
  • It depends on your product. Tablets and most capsules are swallowed whole. Rectal forms are usually used at bedtime. Drink plenty of fluids, and follow your label for food and timi...
  • Headache, gas, belly pain and diarrhea are the common ones. Call your doctor if you get severe cramping with bloody diarrhea, fever or rash, since that could be a reaction to the d...
  • Yes. Your kidney function should be checked before starting and periodically after. If you take azathioprine or 6-mercaptopurine, or are 65 or older, blood counts should be monitor...
📖 Read our full Mesalamine guide →
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 $0.856 $102.71 / 120 tablets
Medicaid paysCMS SDUD · 12 mo $1.63 $196.15 / 120 tablets
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
Dec 2021 Jun 2022 Jan 2024 May 2026 $3.119 $0.856
▼ Down 73% over the last 21 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 Marketing startMarketing endStatus
16714-0830-01 You're viewing this Main listing 120 TABLET, DELAYED RELEASE in 1 BOTTLE 2018-06-25 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mesalamine 1.2 g 00527-3012-48 Lannett 120 tablets $0.781 AB Availability likely save 9%
Mesalamine 1.2 g 00591-2245-22 Actavis 120 tablets $0.781 AB Availability likely save 9%
mesalamine 1.2 g 00904-6832-04 Major 1 tablet $0.781 AB Availability likely save 9%
Mesalamine 1.2 g 60687-0397-25 American 1 tablet $0.781 AB Availability likely save 9%
Mesalamine 1.2 g 62135-0714-12 Chartwell 120 tablets $0.781 AB Availability likely save 9%
Mesalamine 1.2 g 63304-0175-13 Sun 120 tablets $0.781 AB Availability likely save 9%
mesalamine 1.2 g 68382-0711-19 Zydus 120 tablets $0.781 AB Availability likely save 9%
Mesalamine 1.2 g 72603-0304-01 NorthStar 120 tablets $0.781 AB Availability likely save 9%
Mesalamine 1.2 g 54092-0100-01 Takeda 120 tablets $0.795 AB Availability likely save 7%
mesalamine 1.2 gthis 16714-0830-01 Northstar 120 tablets $0.856 AB Discontinued —
Lialda 1.2 g 54092-0476-01 Takeda 120 tablets $8.947 AB Availability likely +945%
Mesalamine 1.2 g 31722-0043-05 Camber 500 tablets — AB FDA listed —
mesalamine 1.2 g 51407-0900-12 Golden 120 tablets — AB FDA listed —
mesalamine 1.2 g 70771-1071-01 Zydus 120 tablets — AB FDA listed —
Mesalamine 1.2 g 72162-2213-02 Bryant 120 tablets — AB FDA listed —
Mesalamine 1.2 g 72162-2231-02 Bryant 120 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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

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

LabelerNorthstar Rx LLC.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA091640 (ANDA)
Labeler code16714
Product typeHuman Prescription Drug
Portfolio28 products on file

More NDCs from Northstar Rx LLC. labeler code 16714

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.

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 – Q4 2025 · 4 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
2.1K
Units reimbursed last 4 qtrs
234.8K
Gross reimbursed last 4 qtrs
$383.8K
Avg / prescription
$184.50
Avg / unit
$1.6346
Latest quarter Q4 2025
44Rx
Medicaid pays / ea
$1.6346
gross reimbursed
vs
NADAC / ea
$0.8559
acquisition cost
=
Spread
+$0.7787
+91% 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 ⓘ
29% FFS 71% MCO
Fee-for-service · 598 Rx Managed care · 1,482 Rx
State Medicaid map
Alaska: 1,350 units · 184 per 100k residents AK Maine: no data reported ME Washington: 48,256 units · 618 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 1,448 units · 24.5 per 100k residents WI Michigan: 3,630 units · 36.2 per 100k residents MI New York: 14,490 units · 74.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 37,965 units · 897 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 6,232 units · 49.7 per 100k residents IL Indiana: no data reported IN Ohio: 2,940 units · 24.9 per 100k residents OH Pennsylvania: 5,280 units · 40.7 per 100k residents PA New Jersey: 5,938 units · 63.9 per 100k residents NJ Massachusetts: no data reported MA California: 39,877 units · 102 per 100k residents CA Utah: 3,600 units · 105 per 100k residents UT Colorado: 3,638 units · 61.9 per 100k residents CO Nebraska: 1,260 units · 63.7 per 100k residents NE Missouri: 7,674 units · 124 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 2,460 units · 39.8 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 9,714 units · 131 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 2,665 units · 24.6 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,230 units · 26.9 per 100k residents LA Mississippi: no data reported MS Alabama: 1,114 units · 21.8 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 32,864 units · 108 per 100k residents TX Florida: 1,140 units · 5.0 per 100k residents FL
Units reimbursed · per 100k residents
5.0897
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 Oregon 897 /100k
2 Washington 618 /100k
3 Alaska 184 /100k
4 Arizona 131 /100k
5 Missouri 124 /100k
6 Texas 108 /100k
7 Utah 105 /100k
8 California 102 /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.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Mesalamine — the program that covers self-administered drugs. 14 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 Mesalamine. 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
$39.58M
Claims incl. refills
102.6K
Beneficiaries
69.2K
Spend / beneficiary
$571.72
Spend / claim
$385.73
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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
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 ✓ 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) ✓ 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

Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Northstar Rx LLC. 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.
← 16714-0829-01 · Northstar 16714-0834-01 · NorthStar →
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.