Ringers sodium chloride, calcium chloride, potassium 860 mg/100mL; 33 mg/100mL; 30 mg/100mL Irrigant
by Baxter Healthcare Corporation · 12 BOTTLE, PLASTIC in 1 CARTON (0338-0104-04) / 1000 mL in 1 BOTTLE, PLASTIC
NDC 00338-0104-04
🏷️ FDA NDC (as labeled)
0338-0104-04
billing pads the labeler segment with a zero
Rx only
Brand
On market
Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
0338-0104-04
Product NDC
0338-0104
11-digit billing NDC
00338010404
NCPDP billing unit
ML — per mL (volume)
RxCUI
847621
UNII
451W47IQ8X, M4I0D6VV5M, 660YQ98I10
Application #
NDA018495
SPL Set ID
e1953d54-818d-46a6-8532-518ebae6d84e
Established class (EPC)
Blood Coagulation Factor; Cations; Inhibition Large Intestine Fluid/Electrolyte Absorption [
Physiologic effect
Increased Coagulation Factor Activity; Increased Large Intestinal Motility
Chemical class
Calcium; Divalent
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1982-02-19
Route
IRRIGATION
Dosage form
IRRIGANT
Substance
SODIUM CHLORIDE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE
GPI-14
99750020002000
GPI class
Ringers Irrigation
GCN Seq No
001428
GCN
04221
HICL code
000614
Ingredient (HICL)
Ringer's Solution
HIC1 code
W
Therapeutic class — broad (HIC1)
Anti-Infecting Agents
HIC2 code
W8
Therapeutic class — intermediate (HIC2)
Antiseptics
HIC3 code
W8F
Therapeutic class — specific (HIC3)
Irrigants
AHFS code
40:36.00.00
AHFS class
Irrigating Solutions
FDB label name
RINGERS IRRIGATION SOLUTION
FDB brand name
Ringers Irrigation
Legend status
F — Federal legend — prescription drug or device
TE code (Orange Book)
AT · RLD · RS
Why two NDCs?
The FDA registers this code as 0338-0104-04 — 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 → 00338-0104-04. 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.
🏷️ RxNorm drug class
This medicine belongs to the Calcium class.
Drug family (ATC)
Calcium, Electrolyte solutions, Acidifiers
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA018495 (NDA)
Labeler code00338
First marketedFeb 1982
Product typeHuman Prescription Drug
Portfolio282 products on file
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.
🩺 Clinical
Label name RINGERS IRRIGATION SOLUTION Ingredient Ringer's Solution
📗 Our plain-language guide HelloPharmacist
- These electrolyte solutions are replacing fluids and minerals your body has lost or needs right now. Think of them as replenishing the building blocks your cells need to function —...
- Why am I being given this IV fluid — what is it actually doing for me?
- Yes — let your nurse know right away if you feel short of breath, notice swelling, develop hives or throat tightness, feel your heart beating irregularly, or feel confused or unusu...
- Is there anything I should watch for while getting this IV?
Patient education
Supplement & herbal interactions
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.
💬 Questions about sodium chloride, calcium chloride, potassium chloride,?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
1 inactive ingredient 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.
💲 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 system | Per each | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ringers .86 g/100mL; .03 g/100mL; .033 g/100mL 00264-2202-00 | B. | 1000 ml | — | AT | FDA listed | — |
| Ringers 860 mg/100mL; 33 mg/100mL; 30 mg/100mLthis 00338-0104-04 | Baxter | 12 bottles | — | AT | FDA listed | — |
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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
🏛️
1982
On the market since
Feb 1982
📍
2026
Currently FDA-listed
44 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00338-0104-04 You're viewing this | 12 BOTTLE, PLASTIC in 1 CARTON (0338-0104-04) / 1000 mL in 1 BOTTLE, PLASTIC | 1982-02-19 | Active |
🧭 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 FDA registers it as 0338-0104-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00338-0104-04, written without dashes as 00338010404. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00338-0104-04, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Corporation; the middle segment (0104) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation 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.
📄 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.
🎯 Indications and Usage
⏱️ Dosage and Administration
📦 How Supplied / Storage and Handling
📋 Description
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Isotonic solution for irrigation only. Not for injection.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Recommended storage: Room temperature (25°C). Avoid excessive heat.
📋 Description ▾
DESCRIPTION Ringer’s Irrigation, USP Each 100 mL contains: 860 mg Sodium Chloride, USP, 33 mg Calcium Chloride, USP, 30 mg Potassium Chloride, USP. No antimicrobial agent has been added. pH 6.0 (5.0 to 7.5). Osmolarity 309 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.