Home › NDC Lookup › Ingredients › Ketorolac Tromethamine › 83854-0021-10
💉image loading
(from DailyMed)

KETROLAC TROMETHAMINE KETOROLAC 15 mg/mL Injection, Solution, 10 vials — NDC 83854-021-10 (Billing 83854-0021-10)

by Anthea Pharma Private Limited · 10 VIAL in 1 CARTON / 1 mL in 1 VIAL

This is a package of 10 vials of KETROLAC TROMETHAMINE KETOROLAC 15 mg/mL Injection, Solution from Anthea Pharma Private Limited, marketed since Sep 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 83854-0021-10
🏷️ FDA NDC (as labeled) 83854-021-10 billing pads the product segment with a zero
This package
Contains10 vials Pack sizes2 compare ↓
Main listing for product 83854-021 · Also comes in: 25 vials 83854-021-25
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 83854-021-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
83854 labeler · 021 product · 10 package
Package marketed since
Sep 25, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8385402110 1
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Ketorolac Tromethamine (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 1, 2025 — Presence of Particulate Matter: Particulate matter identified as glass (Aspiro Pharma Limited) · FDA recall D-0036-2026
Class II · Sep 5, 2025 — Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns (Apotex Corp.) · FDA recall D-0677-2025
Class II · May 28, 2025 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0494-2025
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) 83854-021-10
Product NDC 83854-021
11-digit billing NDC 83854002110
Application # ANDA221041
SPL Set ID 5c9999ae-45e2-b2e5-e063-6294a90a87f6
Established class (EPC) Anti-Inflammatory Agents; Cyclooxygenase Inhibitor; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-25
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance KETOROLAC TROMETHAMINE
Why two NDCs? The FDA registers this code as 83854-021-10 — 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 → 83854-0021-10. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the form. The injection, tablets and Sprix nasal spray are for short-term relief of moderate to moderately severe pain in adults. The eye drops treat eye itching from...
  • For pain, no more than 5 days total, counting injection, tablets and spray together. Taking it longer or at higher doses raises the risk of serious side effects without better reli...
  • No. Ketorolac should not be combined with aspirin or other NSAIDs because the risk of stomach bleeding and other serious effects goes up with no extra benefit. Always check with me...
  • Can I take it with ibuprofen or aspirin?
📖 Read our full Ketorolac guide →
1
Nutrient depletion considerations

Ketorolac Tromethamine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ketorolac Tromethamine 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 mLPer 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: 25 vials
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
83854-0021-10 You're viewing this Main listing 10 VIAL in 1 CARTON / 1 mL in 1 VIAL 2026-09-25 — Active
83854-0021-25 83854-021-25 25 VIAL in 1 CARTON / 1 mL in 1 VIAL 2026-09-25 — Active

Pack size FAQ

What quantity is in this package?
This package contains 10 vials — 10 vial in 1 carton / 1 ml in 1 vial.
How does this package differ from NDC 83854-0021-25?
Both are KETROLAC TROMETHAMINE KETOROLAC 15 mg/mL Injection, Solution — the drug itself is identical. This page's package is the 10 vials one, while NDC 83854-0021-25 is the 25 vials package.
What NDC number is used to bill for this package of KETROLAC TROMETHAMINE KETOROLAC 15 mg/mL Injection, Solution?
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
Ketorolac Tromethamine 15 mg/mL 63323-0161-01 Fresenius 25 vials $0.946 AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 72603-0153-25 NorthStar 25 vials $0.946 AP Discontinued —
Ketorolac Tromethamine 15 mg/mL 70512-0842-25 SOLA 25 vials $0.946 AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 31722-0305-25 Camber 25 vials $0.946 AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 68462-0755-25 GLENMARK 25 vials $0.946 AP FDA listed —
ketorolac tromethamine 15 mg/mL 72266-0234-25 FOSUN 25 vials $0.946 AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 00641-6041-25 Hikma 25 vials $0.946 AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 62332-0599-25 Alembic 25 vials $0.946 AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 65145-0146-25 Caplin 25 vials $0.946 AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 25021-0700-01 Sagent 25 vials $0.946 AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 00409-3793-01 Hospira, 25 vials $0.946 AP Discontinued —
Ketorolac Tromethamine 15 mg/mL 50090-5609-00 A-S 25 vials — AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 50090-6807-00 A-S 25 vials — AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 76045-0107-10 Fresenius 1 syringe — — FDA listed —
Ketorolac Tromethamine 15 mg/mL 72572-0354-10 Civica, 10 vials — AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 83270-0153-03 Onesource 25 vials — — FDA listed —
Ketorolac Tromethamine 15 mg/mL 55154-9366-05 Cardinal 5 vials — AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 70518-4237-00 REMEDYREPACK 25 vials — AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 55154-6960-05 Cardinal 5 vials — AP Discontinued —
Ketorolac Tromethamine 15 mg/mL 00338-0069-10 Baxter 10 vials — AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 83270-0157-01 Onesource 1 syringe — — FDA listed —
Ketorolac Tromethamine 15 mg/mL 72572-0356-25 Civica, 25 vials — AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 55150-0339-01 Eugia 1 vial — — FDA listed —
ketorolac tromethamine 15 mg/mL 68083-0132-10 Gland 10 vials — AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 00404-9998-01 Henry 1 vial — AP FDA listed —
Ketorolac Tromethamine 15 mg/mL 43066-0049-10 Baxter 10 vials — AP FDA listed —
ketorolac tromethamine 15 mg/mL 47335-0933-45 Sun 25 vials — — FDA listed —
Ketrolac Tromethamine 15 mg/mLthis 83854-0021-10 Anthea 10 vials — — 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
On the market since
Sep 2026
📍
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.

🧪 Avoiding an ingredient? See Ketorolac 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

LabelerAnthea Pharma Private Limited
FDA applicationANDA221041 (ANDA)
Labeler code83854
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio22 products on file

More NDCs from Anthea Pharma Private Limited labeler code 83854

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 ↗

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

Medicare Part D (outpatient prescription) spending for Ketorolac Tromethamine (matched by generic name) — the program that covers self-administered drugs. 27 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 Ketorolac Tromethamine. CMS lists 4 products for this generic; we show the highest-spend one. 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
$8.53M
Claims incl. refills
446K
Beneficiaries
349.6K
Spend / beneficiary
$24.38
Spend / claim
$19.12
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
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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) — 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 Anthea Pharma Private Limited. 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 25 vials (83854-0021-25). 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?
Anthea Pharma Private Limited 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.
← 83854-0018-10 · Anthea 83854-0022-25 · Anthea →
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.