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Diltiazem Hydrochloride 180 mg Capsule, Extended Release, 19,000-count — NDC 53360-1211-0 (Billing 53360-1211-00)

by Sanofi Winthrop Industrie · 19000 CAPSULE, EXTENDED RELEASE in 1 DRUM

This is a package of 19,000 capsules of Diltiazem Hydrochloride 180 mg Capsule, Extended Release from Sanofi Winthrop Industrie, marketed since Mar 2012 and currently FDA-listed. It is this product's only package size.

NDC 53360-1211-00
🏷️ FDA NDC (as labeled) 53360-1211-0 billing pads the package segment with a zero
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 53360-1211-0 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
53360 labeler · 1211 product · 0 package
Package marketed since
Mar 1, 2012
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5336012110 7
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Diltiazem Hydrochloride (different manufacturers) — 6 · 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-0342-2025
Class II · Nov 1, 2024 — cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0095-2025
Class II · Nov 1, 2024 — cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0093-2025
Class II · Nov 1, 2024 — cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0094-2025
Class II · Apr 17, 2024 — Failed Dissolution Specifications (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0472-2024
Class II · Mar 26, 2024 — Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0430-2024
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) 53360-1211-0
Product NDC 53360-1211
11-digit billing NDC 53360121100
SPL Set ID f2bf00b9-7f23-2292-e053-2995a90afcab
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-03-01
Dosage form CAPSULE, EXTENDED RELEASE
Substance DILTIAZEM HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 53360-1211-0 — a 5-4-1 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 package segment → 53360-1211-00. 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
  • The pills and capsules you take by mouth are used for high blood pressure and for chronic stable angina, which is chest pain from the heart's workload. Some capsule brands, such as...
  • Usually it's taken once a day, and you should swallow it whole. Don't open, chew or crush the capsules. Some products, like DILT-XR, are best taken in the morning on an empty stoma...
  • How should I take my extended-release capsule or tablet?
  • The most common ones are a stuffy or runny nose, headache, sore throat, constipation, cough, and swelling in the legs or ankles. Most are mild. Call your doctor if you faint, feel...
📖 Read our full Diltiazem guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
2
Nutrient depletion considerations

Diltiazem may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Diltiazem 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 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.
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
53360-1211-00 You're viewing this Main listing 19000 CAPSULE, EXTENDED RELEASE in 1 DRUM — — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diltiazem hydrochloride 180 mg 63304-0719-05 Sun 500 capsules $0.179 — FDA listed —
Diltiazem Hydrochloride Extended-Release 180 mg 10370-0830-05 Endo 500 capsules $0.187 AB3 Discontinued —
Diltiazem Hydrochloride 180 mg 24979-0027-02 Upsher-Smith 500 capsules $0.187 AB3 Availability likely —
Diltiazem Hydrochloride Extended-Release 180 mg 60687-0206-01 American 1 capsule $0.187 AB3 Availability likely —
Cartia XT 180 mg 62037-0598-05 Actavis 500 capsules $0.187 AB3 Availability likely —
Diltiazem Hydrochloride 180 mg 00904-7218-61 Major 1 capsule $0.187 AB3 Availability likely —
Diltiazem Hydrochloride 180 mg 68682-0994-98 OCEANSIDE 90 capsules $0.201 AB3 FDA listed —
Diltiazem Hydrochloride 180 mg 47335-0670-13 Sun 500 capsules $0.218 — FDA listed —
Diltiazem Hydrochloride EXTENDED RELEASE 180 mg 68682-0368-90 Oceanside 90 capsules $0.218 AB4 FDA listed —
Diltiazem Hydrochloride 180 mg 62332-0816-31 Alembic 100 capsules $0.366 AB2 Availability likely —
Diltiazem Hydrochloride 180 mg 70436-0192-01 Slate 100 capsules $0.366 AB2 Availability likely —
Diltiazem Hydrochloride 180 mg 60505-0015-06 Apotex 100 capsules $0.366 AB2 Availability likely —
Diltiazem Hydrochloride 180 mg 16714-0524-01 NORTHSTAR 100 capsules $0.366 AB2 Availability likely —
Diltiazem Hydrochloride 180 mg 16729-0304-01 Accord 100 capsules $0.368 AB2 Availability likely —
Diltiazem Hydrochloride 180 mg 71335-0643-01 Bryant 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 180 mg 47335-0676-13 Sun 500 capsules — — FDA listed —
Diltiazem Hydrochloride Extended-Release 180 mg 71335-1043-01 Bryant 30 capsules — AB3 Discontinued —
Diltiazem Hydrochloride 180 mg 50090-5466-00 A-S 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 180 mg 62332-0726-30 Alembic 30 capsules — AB3 FDA listed —
diltiazem hydrochloride 180 mg 68382-0596-01 Zydus 100 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 180 mg 71335-0266-01 Bryant 30 capsules — AB2 FDA listed —
Cartia XT 180 mg 71335-0879-01 Bryant 30 capsules — AB3 FDA listed —
diltiazem hydrochloride 180 mg 71335-1776-01 Bryant 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 180 mg 33342-0522-02 Macleods 6 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 180 mg 46708-0726-30 Alembic 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 180 mg 55154-4321-00 Cardinal 1 capsule — AB3 FDA listed —
diltiazem hydrochloride 180 mg 70771-1031-01 Zydus 100 capsules — AB3 FDA listed —
diltiazem hydrochloride 180 mg 71335-9708-01 Bryant 30 capsules — AB3 FDA listed —
Cardizem CD 180 mg 00187-0796-30 Bausch 30 capsules — AB3 FDA listed —
Tiadylt Er 180 mg 68382-0746-01 Zydus 100 capsules — AB4 FDA listed —
diltiazem hydrochloride 180 mg 71335-2602-01 Bryant 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 180 mg 46708-0816-31 Alembic 100 capsules — AB2 FDA listed —
Diltiazem Hydrochloride 180 mg 51407-0474-90 Golden 90 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 180 mg 71335-0634-01 Bryant 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 180 mg 71335-2739-01 Bryant 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 180 mgthis 53360-1211-00 Sanofi 19000 capsules — — FDA listed —
diltiazem hydrochloride 180 mg 00615-8380-39 NCS 30 capsules — AB3 FDA listed —
Tiazac Extended Release 180 mg 00187-2613-30 Bausch 30 capsules — AB4 FDA listed —
diltiazem hydrochloride 180 mg 50742-0249-05 Ingenus 500 capsules — AB3 FDA listed —
Tiadylt Er 180 mg 70771-1036-00 Zydus 1000 capsules — AB4 FDA listed —
Diltiazem Hydrochloride Extended-Release 180 mg 71335-1063-01 Bryant 30 capsules — AB3 Discontinued —
diltiazem hydrochloride 180 mg 84677-0040-90 Golden 90 capsules — AB3 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

🏛️
2012
On the market since
Mar 2012
📍
2026
Currently FDA-listed
14 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 Diltiazem 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerSanofi Winthrop Industrie
Labeler code53360
First marketedMar 2012
Product typeDrug For Further Processing
Portfolio30 products on file

More NDCs from Sanofi Winthrop Industrie labeler code 53360

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 ↗

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: Sanofi Winthrop Industrie 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) — 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

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.
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 Sanofi Winthrop Industrie. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sanofi Winthrop Industrie 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.
← 53360-1210-00 · Sanofi 53360-1212-00 · Sanofi →
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.