![Rotarix Rotavirus Vaccine, Live, Oral 1000 [CCID_50]/mL Solution, 10 applicators — NDC 58160-0740-21 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f3182470-1965-4e20-dbaf-e3506f893ea5&name=rotarix-spl-graphic-12.jpg)
Rotarix Rotavirus Vaccine, Live, Oral 1000 [CCID_50]/mL Solution, 10 applicators
by GlaxoSmithKline Biologicals SA · 10 APPLICATOR in 1 CARTON (58160-740-21) / 1.5 mL in 1 APPLICATOR (58160-740-02)
NDC 58160-0740-21
🏷️ FDA NDC (as labeled)
58160-740-21
billing pads the product segment with a zero
Brand
On market
Non-controlled
🗂️ Data synced Sep 10, 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)
58160-740-21
Product NDC
58160-740
11-digit billing NDC
58160074021
NCPDP billing unit
ML — per mL (volume)
Application #
BLA125265
SPL Set ID
f3182470-1965-4e20-dbaf-e3506f893ea5
Established class (EPC)
Live Attenuated Rotavirus Vaccine; Vaccines
Physiologic effect
Actively Acquired Immunity
Chemical class
Rotavirus Vaccines; Attenuated
DEA schedule
Non-controlled
Marketing category
BLA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-02-01
Route
ORAL
Dosage form
SOLUTION
Substance
HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN
GCN Seq No
065226
GCN
24276
HICL code
033669
Ingredient (HICL)
Rotavirus Vac,Live Att, 89-12
HIC1 code
W
Therapeutic class — broad (HIC1)
Anti-Infecting Agents
HIC2 code
W7
Therapeutic class — intermediate (HIC2)
Biologicals
HIC3 code
W7H
Therapeutic class — specific (HIC3)
Enteric Virus Vaccines
AHFS code
80:12.00.00
AHFS class
Vaccines
FDB label name
ROTARIX VACCINE ORAL SYRINGE
FDB brand name
Rotarix
Legend status
F — Federal legend — prescription drug or device
Biologic (Purple Book)
351(a)
Why two NDCs?
The FDA registers this code as 58160-740-21 — 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 → 58160-0740-21. 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.
🏭 Manufacturer & labeler
LabelerGlaxoSmithKline Biologicals SA
FDA applicationBLA125265 (BLA)
Labeler code58160
First marketedFeb 2023
Product typeVaccine
Portfolio26 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 ROTARIX VACCINE ORAL SYRINGE Ingredient Rotavirus Vac,Live Att, 89-12
📖 What it is MedlinePlus · NLM
Why get vaccinated? Rotavirus live vaccine may prevent gastroenteritis (serious diarrhea and vomiting) that may occur with infection due to certain types of rotavirus viruses. Infection with rotavirus can cause serious dehydration (loss of body fluids) that may result in hospitalization. Rotavirus live vaccine contains 4 strains or live virus that has been weakened so it does not cause disease but can still stimulate the body to make antibodies against the virus to provide a defense against potential infection. This vaccine does not offer full protection against rotavirus gastroenteritis. The...
Read the full MedlinePlus article ↗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 Rotavirus Vaccine, Live, Oral?
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 5SL0G7R0OK
A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
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UNII M4I0D6VV5M
Calcium chloride is a salt compound that acts as a firming agent and source of calcium ions in medications. It's used in formulations to help maintain tablet structure, improve texture, or serve as a buffering agent.
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UNII 48TCX9A1VT
Cystine is an amino acid (a building block of proteins) used in some formulations as a buffering agent and antioxidant to help stabilize the medicine and maintain its effectiveness during storage.
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UNII N8H8402XOB
Ferric nitrate is an iron-containing salt used as a colorant in medicines. It may give tablets or capsules a yellow or brown tint while serving no therapeutic purpose.
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UNII 0RH81L854J
Glutamine is an amino acid, a natural building block of proteins. In medicines, it may serve as a buffering agent to help stabilize the product's pH and maintain its chemical stability.
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UNII DE08037SAB
Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
-
UNII 660YQ98I10
Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
-
UNII 3XG6T5KYKM
Sodium adipate is a salt derived from adipic acid. In medicines, it acts as a buffer to help maintain proper acidity levels and may also serve as a pH regulator in liquid or solid formulations.
-
UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 3980JIH2SW
A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
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UNII POD38AIF08
Sodium pyruvate is a salt form of pyruvic acid, a naturally occurring compound. It's used in medicines as a buffer to help maintain the product's pH and stability.
-
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
-
UNII 42HK56048U
Tyrosine is an amino acid, a building block of proteins. In medicines, it's used as a buffering agent to help stabilize the product's pH and improve its chemical stability during storage.
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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.
15 inactive ingredients 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 mL | 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 |
|---|---|---|---|---|---|---|
| Rotarix 1000 [CCID_50]/mLthis 58160-0740-21 | GlaxoSmithKline | 10 applicators | — | — | FDA listed | — |
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status
🏛️
2008
First FDA approval
Apr 2008
📍
2026
Currently FDA-listed
18 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
FDA Purple Book — biosimilars & interchangeables
ⓘ
Reference product
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 58160-0740-21 You're viewing this | 10 APPLICATOR in 1 CARTON (58160-740-21) / 1.5 mL in 1 APPLICATOR (58160-740-02) | 2023-02-01 | Active |
🧭 About this NDC listing & data coverage
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 | — 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 FDA registers it as 58160-740-21, 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: 58160-0740-21, written without dashes as 58160074021. 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 58160-0740-21, the first segment (58160) is the labeler code FDA assigned to GlaxoSmithKline Biologicals SA; the middle segment (0740) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (21) 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 GlaxoSmithKline Biologicals SA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GlaxoSmithKline Biologicals SA 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.
📄 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 ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
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.