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Glycerol phenylbutyrate 1.1 g/mL Liquid — NDC 00480-3777-58 package photo
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Glycerol phenylbutyrate 1.1 g/mL Liquid — NDC 0480-3777-58 (Billing 00480-3777-58)

by Teva Pharmaceuticals, Inc. · 1 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE

This is a package of Glycerol phenylbutyrate 1.1 g/mL Liquid from Teva Pharmaceuticals, Inc., marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 00480-3777-58
🏷️ FDA NDC (as labeled) 0480-3777-58 billing pads the labeler segment with a zero
Rx only Generic 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 →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0480-3777-58
Product NDC 0480-3777
11-digit billing NDC 00480377758
NCPDP billing unit ML — per mL (volume)
RxCUI 1368453
UNII ZH6F1VCV7B
Application # ANDA218738
SPL Set ID 28bb5ec0-a99f-4774-b8a8-b6c229b89ba5
Established class (EPC) Nitrogen Binding Agent
Mechanism of action Ammonium Ion Binding Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-16
Route ORAL
Dosage form LIQUID
Substance GLYCEROL PHENYLBUTYRATE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 30908030000920
GCN Seq No 070560
GCN 34137
HICL code 039990
Ingredient (HICL) Glycerol Phenylbutyrate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D9
Therapeutic class — intermediate (HIC2) Ammonia Inhibitors
HIC3 code D9A
Therapeutic class — specific (HIC3) Ammonia Inhibitors
AHFS code 40:10.00.00
AHFS class Ammonia Detoxicants
FDB label name GLYCEROL PHENYLBUT 1.1 GRAM/ML
FDB brand name Glycerol Phenylbutyrate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 070560
  • GCN: 34137
  • GPI-14 (Medi-Span): 30908030000920
  • HICL (First Databank): 039990
  • AHFS class code: 40:10.00.00
  • RxCUI (RxNorm): 1368453
Why two NDCs? The FDA registers this code as 0480-3777-58 — 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 → 00480-3777-58. 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 Various alimentary tract and metabolism products class.

Drug family (ATC) Various alimentary tract and metabolism products
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.

Clinical

Label name GLYCEROL PHENYLBUT 1.1 GRAM/ML Ingredient Glycerol Phenylbutyrate
📖 What it is MedlinePlus · NLM

Glycerol phenylbutyrate is used to manage urea cycle disorders (UCDs; an inherited condition that affects the ability to metabolize protein). Glycerol phenylbutyrate is in a class of medications called nitrogen binding agents. It works by lowering ammonia levels in the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps manage urea cycle disorders over the long term. These are inherited conditions that let ammonia build up. It works alongside your low-protein diet, not instead of it, and...
  • Take it by mouth with food or formula. Use a new, dry oral syringe for each dose and squirt it directly into the mouth. Discard the bottle 28 days after opening. Toss it if it look...
  • The most common are diarrhea, gas, and headache. Some people also have nausea, vomiting, tiredness, or less appetite. Call your doctor if you have unusual sleepiness, confusion, or...
  • Tell us about everything you take. Steroids, valproic acid, and haloperidol can raise ammonia. Probenecid, midazolam, and certain narrow-margin drugs like cyclosporine can interact...
📖 Read our full Glycerol Phenylbutyrate 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 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 · Q2 2026 $164.11 $4,102.63 / 25 ml
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
00480-3777-58 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE 2026-04-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glycerol phenylbutyrate 1.1 g/mLthis 00480-3777-58 Teva 1 bottle — AA FDA listed —
Glycerol Phenylbutyrate 1.1 g/mL 31722-0605-31 Camber 1 bottle — AA FDA listed —
Glycerol Phenylbutyrate 1.1 g/mL 49884-0264-95 Par 1 bottle — AA FDA listed —
Glycerol Phenylbutyrate 1.1 g/mL 59651-0988-25 Aurobindo 1 bottle — AA FDA listed —
Glycerol Phenylbutyrate 1.1 g/mL 70710-2193-05 Zydus 1 bottle — AA FDA listed —
glycerol phenylbutyrate 1.1 g/mL 70748-0425-01 Lupin 1 bottle — AA FDA listed —
Glycerol phenylbutyrate 1.1 g/mL 72205-0331-57 Novadoz 1 bottle — AA FDA listed —
Ravicti 1.1 g/mL 75987-0050-06 Horizon 1 bottle — AA FDA listed —
Glycerol Phenylbutyrate 1.1 g/mL 68475-0807-01 Navinta 1 bottle — AA 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
Apr 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerTeva Pharmaceuticals, Inc.
Application holderTEVA PHARMACEUTICALS INC
FDA applicationANDA218738 (ANDA)
Labeler code00480
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio166 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.

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 210 words ▾

1 INDICATIONS AND USAGE Glycerol phenylbutyrate oral liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). Limitations of Use: Glycerol phenylbutyrate oral liquid is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels.

The safety and efficacy of glycerol phenylbutyrate oral liquid for the treatment of N- acetylglutamate synthase (NAGS) deficiency has not been established. Glycerol phenylbutyrate oral liquid is a nitrogen-binding agent indicated for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements.

( 1 ) Limitations of Use: Glycerol phenylbutyrate oral liquid is not indicated for treatment of acute hyperammonemia in patients with UCDs. ( 1 ) Safety and efficacy for treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Glycerol phenylbutyrate oral liquid should be prescribed by a physician experienced in management of UCDs. For administration and preparation, see full prescribing information. ( 2.1 , 2.6 ) Switching From Sodium Phenylbutyrate Tablets or Powder to Glycerol Phenylbutyrate Oral Liquid: Patients should receive the dosage of glycerol phenylbutyrate oral liquid that contains the same amount of phenylbutyric acid, see full prescribing information for conversion.

( 2.2 ) Initial Dosage in Phenylbutyrate-Naïve Patie nts ( 2.3 ): Recommended dosage range is 4.5 to 11.2 mL/m 2 /day (5 to 12.4 g/m 2 /day). For patients with some residual enzyme activity not adequately controlled with dietary restriction, the recommended starting dose is 4.5 mL/m 2 /day. Take into account patient's estimated urea synthetic capacity, dietary protein intake, and diet adherence.

Dosage Adjustment and Monitoring: Follow plasma ammonia levels to determine the need for dosage titration. ( 2.4 ) Dosage Modifications in Patients with Hepatic Impairment: Start dosage at lower end of range. ( 2.5 , 8.7 )

2.1Important Administration Instructions Glycerol phenylbutyrate oral liquid should be prescribed by a physician experienced in the management of UCDs. Instruct patients to take glycerol phenylbutyrate oral liquid with food or formula and to administer directly into the mouth via oral syringe. Instruct patients to use the glycerol phenylbutyrate oral liquid bottle and oral syringe as follows: Use a new reclosable bottle cap adapter with each new bottle that is opened.

Open the glycerol phenylbutyrate oral liquid bottle and twist on the new reclosable bottle cap adapter. Use a new and dry oral syringe to withdraw each prescribed dose of glycerol phenylbutyrate oral liquid. Discard the oral syringe after each dose.

Tightly close the tethered tab on the reclosable bottle cap adapter after each use. Do not rinse the reclosable bottle cap adapter. Discard bottle and any remaining contents 28 days after opening.

If water or moisture enters the glycerol phenylbutyrate oral liquid bottle, the contents will become cloudy in appearance. If the contents of the bottle appear cloudy at any time, do not use the remaining glycerol phenylbutyrate oral liquid in the bottle and return it to the pharmacy to be discarded. Instruct that glycerol phenylbutyrate oral liquid should be administered just prior to breastfeeding in infants who are breastfeeding.

For patients who cannot swallow, see the instructions on administration of glycerol phenylbutyrate oral liquid by nasogastric tube or gastrostomy tube [see Dosage and Administration ( 2.6 )] . For patients who require a volume of less than 1 mL per dose via nasogastric or gastrostomy tube, the delivered dose may be less than anticipated. Closely monitor these patients using ammonia levels [see Dosage and Administration ( 2.6 )] .

The recommended dosages for patients switching from sodium phenylbutyrate to glycerol phenylbutyrate oral liquid and patients naïve to phenylbutyric acid are different [see Dosage and Administration ( 2.2 , 2.3 )] . For both subpopulations: Patients 2 years of age and older: Give glycerol phenylbutyrate oral liquid in 3 equally divided dosages, each rounded up to the nearest 0.5 mL Patients less than 2 years: Give glycerol phenylbutyrate oral liquid in 3 or more equally divided dosages, each rounded up to the nearest 0.1 mL.

The maximum total daily dosage is 17.5 mL (19 g). Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

2.2Switching From Sodium Phenylbutyrate to Glycerol Phenylbutyrate Oral Liquid Patients switching from sodium phenylbutyrate to glycerol phenylbutyrate oral liquid should receive the dosage of glycerol phenylbutyrate oral liquid that contains the same amount of phenylbutyric acid. The conversion is as fo…

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral liquid: clear, colorless to pale yellow, 1.1 g/mL of glycerol phenylbutyrate (delivers 1.02 g/mL of phenylbutyrate). Oral liquid: 1.1 g/mL. ( 3 )

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS Glycerol phenylbutyrate oral liquid is contraindicated in patients with known hypersensitivity to phenylbutyrate. Signs of hypersensitivity include wheezing, dyspnea, coughing, hypotension, flushing, nausea, and rash. Known hypersensitivity to phenylbutyrate. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Neurotoxicity : Phenylacetate (PAA), the active moiety of glycerol phenylbutyrate oral liquid, may be toxic; reduce dosage for symptoms of neurotoxicity. ( 5.1 ) Pancreatic Insufficiency or Intestinal Malabsorption : Monitor ammonia levels closely. ( 5.2 )

5.1Neurotoxicity Increased exposure to PAA, the major metabolite of glycerol phenylbutyrate oral liquid, may be associated with neurotoxicity in patients with UCDs. In a study of adult cancer patients, subjects received sodium phenylacetate administered as a 1-hour infusion twice daily at two dose levels of 125 and 150 mg/kg for a 2-week period. Of 18 subjects enrolled, 7 had a history of primary central nervous system tumor.

Signs and symptoms of potential PAA neurotoxicity, which were reversible, were reported at plasma PAA concentrations above 500 micrograms/mL and included somnolence, fatigue, lightheadedness, headache, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of preexisting neuropathy. PAA concentrations were not measured when symptoms resolved. In healthy subjects, after administration of 4 mL and 6 mL glycerol phenylbutyrate oral liquid 3 times daily (13.2 g/day and 19.8 g/day, respectively) for 3 days, a dose-dependent increase in non-serious nervous system adverse reactions were observed.

In subjects who had nervous system adverse reactions, plasma PAA concentrations, which were measured on Day 3 per protocol and not always at onset of symptoms, ranged from 8 to 56 micrograms/mL with 4 mL glycerol phenylbutyrate oral liquid 3 times daily and from 31 to 242 micrograms/mL with 6 mL glycerol phenylbutyrate oral liquid 3 times daily. In clinical trials in patients with UCDs who had been on sodium phenylbutyrate prior to administration of glycerol phenylbutyrate oral liquid, adverse reactions of headache, fatigue, symptoms of peripheral neuropathy, seizures, tremor and/or dizziness were reported.

No correlation between plasma PAA concentration and neurologic symptoms was identified but plasma PAA concentrations were generally not consistently measured at the time of neurologic symptom occurrence [see Clinical Pharmacology ( 12.3 )] . If symptoms of vomiting, nausea, headache, somnolence or confusion are present in the absence of high ammonia or other intercurrent illness which explains these symptoms, consider the potential for PAA neurotoxicity which may need reduction in the glycerol phenylbutyrate oral liquid dosage [see Dosage and Administration ( 2.4 )] .

5.2Pancreatic Insufficiency or Intestinal Malabsorption Exocrine pancreatic enzymes hydrolyze glycerol phenylbutyrate oral liquid in the small intestine, separating the active moiety, phenylbutyrate, from glycerol. This process allows phenylbutyrate to be absorbed into the circulation. Low or absent pancreatic enzymes or intestinal disease resulting in fat malabsorption may result in reduced or absent digestion of glycerol phenylbutyrate oral liquid and/or absorption of phenylbutyrate and reduced control of plasma ammonia.

Monitor ammonia levels closely in patients with pancreatic insufficiency or intestinal malabsorption.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Neurotoxicity [see Warnings and Precautions ( 5.1 )] Pancreatic insufficiency or Intestinal Malabsorption [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (≥10%) in adults are: diarrhea, flatulence, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Assessment of adverse reactions was based on exposure of 45 adult patients (31 female and 14 male) with UCD subtype deficiencies of ornithine transcarbamylase (OTC, n=40), carbamoyl phosphate synthetase (CPS, n=2), and argininosuccinate synthetase (ASS, n=1) in a randomized, double-blind, active-controlled (glycerol phenylbutyrate oral liquid vs sodium phenylbutyrate), crossover, 4-week study (Study 1) that enrolled patients 18 years of age and older [see Clinical Studies ( 14.1 )] .

One of the 45 patients received only sodium phenylbutyrate prior to withdrawing on day 1 of the study due to an adverse reaction. The most common adverse reactions (occurring in at least 10% of patients) reported during short-term treatment with glycerol phenylbutyrate oral liquid were diarrhea, flatulence, and headache. Table 1 summarizes adverse reactions occurring in 2 or more patients treated with glycerol phenylbutyrate oral liquid or sodium phenylbutyrate (incidence of at least 4% in either treatment arm).

Table 1: Adverse Reactions Reported in 2 or More Adult Patients with UCDs (at least 4% in Either Treatment Arm) in Study 1 Number (%) of Patients in Study 1 Sodium Phenylbutyrate (N = 45) Glycerol Phenylbutyrate Oral Liquid (N = 44) Diarrhea 3 (7) 7 (16) Headache 4 (9) 6 (14) Flatulence 1 (2) 6 (14) Abdominal pain 2 (4) 3 (7) Vomiting 2 (4) 3 (7) Decreased appetite 2 (4) 3 (7) Fatigue 1 (2) 3 (7) Dyspepsia 3 (7) 2 (5) Nausea 3 (7) 1 (2) Dizziness 4 (9) 0 Abdominal discomfort 3 (7) 0 Other Adverse Reactions Glycerol phenylbutyrate oral liquid has been evaluated in 77 patients with UCDs (51 adult and 26 pediatric patients ages 2 years to 17 years) in 2 open-label long-term studies, in which 69 patients completed 12 months of treatment with glycerol phenylbutyrate oral liquid (median exposure=51 weeks).

During these studies there were no deaths. Adverse reactions reported in at least 10% of adult patients were nausea, vomiting, diarrhea, decreased appetite, dizziness, headache, and fatigue. Adverse reactions reported in at least 10% of pediatric patients ages 2 years to 17 years were upper abdominal pain, rash, nausea, vomiting, diarrhea, decreased appetite, and headache.

Glycerol phenylbutyrate oral liquid has been evaluated in 17 patients with UCDs ages 2 months to less than 2 years in 3 open-label studies. The median exposure was 6 months (range 0.2 to 20 months). Adverse reactions reported in at least 10% of pediatric patients aged 2 months to less than 2 years were neutropenia, vomiting, constipation, diarrhea, pyrexia, hypophagia, cough, nasal congestion, rhinorrhea, rash, and papule.

Glycerol phenylbutyrate oral liquid has been evaluated in 16 patients with UCDs less than 2 months of age (age range 0.1 to 2 months, median age 0.5 months) in a single, open-label study. The median exposure was 10 months (range 2 to 20 months). Adverse reactions reported in at least 10% of pediatric patients aged less than 2 months were vomiting, rash, gastroesophageal reflux, increased hepatic enzymes, feeding disorder (decreased appetite, hypophagia), anemia, cough, dehydration, metabolic acidosis, thrombocytosis, thrombocytopenia, neutropenia, lymphocytosis, diarrhea, flatulence, consti…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Corticosteroids, valproic acid, or haloperidol : May increase plasma ammonia level; monitor ammonia levels closely. ( 7.1 ) Probenecid : May affect renal excretion of metabolites of glycerol phenylbutyrate oral liquid, including phenylacetylglutamine (PAGN) and PAA. ( 7.2 ) CYP3A4 Substrates with narrow therapeutic index (e.g., alfentanil, quinidine, cyclosporine) : Glycerol phenylbutyrate oral liquid may decrease exposure; monitor for decreased efficacy of the narrow therapeutic index drug.

( 7.3 ) Midazolam : Decreased exposure; monitor for suboptimal effect of midazolam. ( 7.3 )

7.1Potential for Other Drugs to Affect Ammonia Corticosteroids Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels. Monitor ammonia levels closely when corticosteroids and glycerol phenylbutyrate oral liquid are used concomitantly. Valproic Acid and Haloperidol Hyperammonemia may be induced by haloperidol and by valproic acid.

Monitor ammonia levels closely when use of valproic acid or haloperidol is necessary in patients with UCDs.

7.2Potential for Other Drugs to Affect Glycerol Phenylbutyrate Oral Liquid Probenecid Probenecid may inhibit the renal excretion of metabolites of glycerol phenylbutyrate oral liquid including PAGN and PAA.

7.3Potential for Glycerol Phenylbutyrate Oral Liquid to Affect Other Drugs Drugs with narrow therapeutic index that are substrates of CYP3A4 Glycerol phenylbutyrate oral liquid is a weak inducer of CYP3A4 in humans. Concomitant use of glycerol phenylbutyrate oral liquid may decrease the systemic exposure to drugs that are substrates of CYP3A4. Monitor for decreased efficacy of drugs with narrow therapeutic index (e.g., alfentanil, quinidine, cyclosporine) [see Clinical Pharmacology ( 12.3 )] .

Midazolam Concomitant use of glycerol phenylbutyrate oral liquid decreased the systemic exposure of midazolam. Monitor for suboptimal effect of midazolam in patients who are being treated with glycerol phenylbutyrate oral liquid.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Breastfeeding is not recommended. ( 8.2 )

8.1Pregnancy Risk Summary Limited available data with glycerol phenylbutyrate oral liquid use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. In an animal reproduction study, administration of oral glycerol phenylbutyrate to pregnant rabbits during organogenesis at doses up to 2.7– times the dose of 6.87 mL/m 2 /day in adult patients resulted in maternal toxicity, but had no effects on embryo-fetal development. In addition, there were no adverse developmental effects with administration of oral glycerol phenylbutyrate to pregnant rats during organogenesis at 1.9 times the dose of 6.87 mL/m 2 /day in adult patients; however, maternal toxicity, reduced fetal weights, and variations in skeletal development were observed in pregnant rats administered oral glycerol phenylbutyrate during organogenesis at doses greater than or equal to 5.7 times the dose of 6.87 mL/m 2 /day in adult patients [see Data] .

Report pregnancies to Teva at 1-888-838-2872. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Oral administration of glycerol phenylbutyrate during the period of organogenesis up to 350 mg/kg/day in rabbits produced maternal toxicity, but no effects on embryo-fetal development. The dose of 350 mg/kg/day in rabbits is approximately 2.7 times the dose of 6.87 mL/m 2 /day in adult patients, based on combined area under the plasma concentration-time curve [AUCs] for PBA and PAA.

In rats, at an oral dose of 300 mg/kg/day of glycerol phenylbutyrate (1.9 times the dose of 6.87 mL/m 2 /day in adult patients, based on combined AUCs for PBA and PAA) during the period of organogenesis, no effects on embryo-fetal development were observed. Doses of 650 mg/kg/day or greater produced maternal toxicity and adverse effects on embryo-fetal development including reduced fetal weights and cervical ribs at the 7th cervical vertebra. The dose of 650 mg/kg/day in rats is approximately 5.7 times the dose of 6.87 mL/m 2 /day in adult patients, based on combined AUCs for PBA and PAA.

No developmental abnormalities, effects on growth, or effects on learning and memory were observed through maturation of offspring following oral administration in pregnant rats with up to 900 mg/kg/day of glycerol phenylbutyrate (8.5 times the dose of 6.87 mL/m 2 /day in adult patients, based on combined AUCs for PBA and PAA) during organogenesis and lactation.

8.2Lactation Risk Summary There are no data on the presence of glycerol phenylbutyrate oral liquid in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions, including neurotoxicity and tumorigenicity in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with glycerol phenylbutyrate oral liquid.

8.4Pediatric Use Patients 2 Years to 17 Years of Age The safety and effectiveness of glycerol phenylbutyrate oral liquid in patients 2 years to less than 18 years of age have been established in 3 clinical studies: 2 open-label, fixed-sequence, switchover clinical studies from sodium phenylbutyrate to glycerol phenylbutyrate oral liquid, and 1 long-term, open label safety study [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.2 )] . Patients Less Than 2 Years of Age The safety and effectiveness of glycerol phenylbutyrate oral liquid in patients with UCDs less than 2 years of age have been established in 3 open-label studies.

Pharmacokinetics and pharmacodynamics (plasma ammonia), and safety were studied in 17 patients ag…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Limited available data with glycerol phenylbutyrate oral liquid use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. In an animal reproduction study, administration of oral glycerol phenylbutyrate to pregnant rabbits during organogenesis at doses up to 2.7– times the dose of 6.87 mL/m 2 /day in adult patients resulted in maternal toxicity, but had no effects on embryo-fetal development. In addition, there were no adverse developmental effects with administration of oral glycerol phenylbutyrate to pregnant rats during organogenesis at 1.9 times the dose of 6.87 mL/m 2 /day in adult patients; however, maternal toxicity, reduced fetal weights, and variations in skeletal development were observed in pregnant rats administered oral glycerol phenylbutyrate during organogenesis at doses greater than or equal to 5.7 times the dose of 6.87 mL/m 2 /day in adult patients [see Data] .

Report pregnancies to Teva at 1-888-838-2872. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Oral administration of glycerol phenylbutyrate during the period of organogenesis up to 350 mg/kg/day in rabbits produced maternal toxicity, but no effects on embryo-fetal development. The dose of 350 mg/kg/day in rabbits is approximately 2.7 times the dose of 6.87 mL/m 2 /day in adult patients, based on combined area under the plasma concentration-time curve [AUCs] for PBA and PAA.

In rats, at an oral dose of 300 mg/kg/day of glycerol phenylbutyrate (1.9 times the dose of 6.87 mL/m 2 /day in adult patients, based on combined AUCs for PBA and PAA) during the period of organogenesis, no effects on embryo-fetal development were observed. Doses of 650 mg/kg/day or greater produced maternal toxicity and adverse effects on embryo-fetal development including reduced fetal weights and cervical ribs at the 7th cervical vertebra. The dose of 650 mg/kg/day in rats is approximately 5.7 times the dose of 6.87 mL/m 2 /day in adult patients, based on combined AUCs for PBA and PAA.

No developmental abnormalities, effects on growth, or effects on learning and memory were observed through maturation of offspring following oral administration in pregnant rats with up to 900 mg/kg/day of glycerol phenylbutyrate (8.5 times the dose of 6.87 mL/m 2 /day in adult patients, based on combined AUCs for PBA and PAA) during organogenesis and lactation.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Patients 2 Years to 17 Years of Age The safety and effectiveness of glycerol phenylbutyrate oral liquid in patients 2 years to less than 18 years of age have been established in 3 clinical studies: 2 open-label, fixed-sequence, switchover clinical studies from sodium phenylbutyrate to glycerol phenylbutyrate oral liquid, and 1 long-term, open label safety study [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.2 )] . Patients Less Than 2 Years of Age The safety and effectiveness of glycerol phenylbutyrate oral liquid in patients with UCDs less than 2 years of age have been established in 3 open-label studies.

Pharmacokinetics and pharmacodynamics (plasma ammonia), and safety were studied in 17 patients aged 2 months to less than 2 years of age and in 16 patients less than 2 months of age [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.3 )] . Juvenile Animal Toxicity Data In a juvenile rat study with daily oral dosing performed on postpartum day 2 through mating and pregnancy after maturation, terminal body weight was dose-dependently reduced by up to 16% in males and 12% in females at 900 mg/kg/day or higher (3 times the dose of 6.87 mL/m 2 /day in adult patients, based on combined AUCs for PBA and PAA).

Learning, memory, and motor activity endpoints were not affected. However, fertility (number of pregnant rats) was decreased by up to 25% at 650 mg/kg/day or higher (2.6 times the dose of 6.87 mL/m 2 /day in adult patients, based on combined AUCs for PBA and PAA).

🧓 Geriatric Use 88 words ▾

8.5Geriatric Use Clinical studies of glycerol phenylbutyrate oral liquid did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 58 words ▾

10 OVERDOSAGE While there is no experience with overdosage in human clinical trials, PAA, a toxic metabolite of glycerol phenylbutyrate oral liquid, can accumulate in patients who receive an overdose [see Warnings and Precautions ( 5.1 )] . If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action UCDs are inherited deficiencies of enzymes or transporters necessary for the synthesis of urea from ammonia (NH 3 , NH 4 + ). Absence of these enzymes or transporters results in the accumulation of toxic levels of ammonia in the blood and brain of affected patients. Glycerol phenylbutyrate oral liquid is a triglyceride containing 3 molecules of PBA.

PAA, the major metabolite of PBA, is the active moiety of glycerol phenylbutyrate oral liquid. PAA conjugates with glutamine (which contains 2 molecules of nitrogen) via acetylation in the liver and kidneys to form PAGN, which is excreted by the kidneys (Figure 1). On a molar basis, PAGN, like urea, contains 2 moles of nitrogen and provides an alternate vehicle for waste nitrogen excretion.

Figure 1: Glycerol Phenylbutyrate Oral Liquid Mechanism of Action fig. 1

12.2Pharmacodynamics Pharmacological Effects In clinical studies, total 24-hour area under the plasma concentration-time curve (AUC) of ammonia levels was comparable at steady state during the switchover period between glycerol phenylbutyrate oral liquid and sodium phenylbutyrate [see Clinical Studies ( 14 )] . Cardiac Electrophysiology The effect of multiple doses of glycerol phenylbutyrate oral liquid 13.2 g/day and 19.8 g/day (approximately 69% and 104% of the maximum recommended daily dosage) on QTc interval was evaluated in a randomized, placebo- and active-controlled (moxifloxacin 400 mg), four-treatment-arm, crossover study in 57 healthy subjects.

The upper bound of the one-sided 95% CI for the largest placebo-adjusted, baseline-corrected QTc, based on individual correction method (QTcI) for glycerol phenylbutyrate oral liquid, was below 10 ms.

12.3Pharmacokinetics Absorption Glycerol phenylbutyrate oral liquid is a pro-drug of PBA. Upon oral ingestion, PBA is released from the glycerol backbone in the gastrointestinal tract by lipases. PBA derived from glycerol phenylbutyrate oral liquid is further converted by β-oxidation to PAA.

In healthy, fasting adult subjects receiving a single oral dose of 2.9 mL/m 2 of glycerol phenylbutyrate oral liquid, peak plasma levels of PBA, PAA, and PAGN occurred at 2 hours, 4 hours, and 4 hours, respectively. Upon single-dose administration of glycerol phenylbutyrate oral liquid, plasma concentrations of PBA were quantifiable in 15 of 22 participants at the first sample time postdose (0.25 hours). Mean maximum concentration (C max ) for PBA, PAA, and PAGN was 37.0 micrograms/mL, 14.9 micrograms/mL, and 30.2 micrograms/mL, respectively.

In healthy subjects, intact glycerol phenylbutyrate was detected in plasma. While the study was inconclusive, the incomplete hydrolysis of glycerol phenylbutyrate cannot be ruled out. In healthy subjects, the systemic exposure to PAA, PBA, and PAGN increased in a dose-dependent manner.

Following 4 mL of glycerol phenylbutyrate oral liquid 3 times a day for 3 days, the mean C max and AUC were 66 micrograms/mL and 930 micrograms•h/mL for PBA and 28 micrograms/mL and 942 micrograms•h/mL for PAA, respectively. In the same study, following 6 mL of glycerol phenylbutyrate oral liquid three times a day for 3 days, mean C max and AUC were 100 micrograms/mL and 1400 micrograms•h/mL for PBA and 65 µg/mL and 2064 micrograms•h/mL for PAA, respectively. In adult patients with UCDs receiving multiple doses of glycerol phenylbutyrate oral liquid, maximum plasma concentrations at steady state (C max,ss ) of PBA, PAA, and PAGN occurred at 8 hours, 12 hours, and 10 hours, respectively, after the first dose in the day.

Intact glycerol phenylbutyrate was not detectable in plasma in patients with UCDs. In clinical studies of glycerol phenylbutyrate oral liquid in patients with UCDs, the peak observed PAA concentrations by age group are shown in Table 2. Table 2: Peak PAA Concentrations in Patients with UCDs Treated with Glycerol Phenylbutyrate Oral Liquid in Clinical Trials Age Range Glycerol Phenylbutyrate Oral Liquid D…

🧬 Mechanism of Action 137 words ▾

12.1Mechanism of Action UCDs are inherited deficiencies of enzymes or transporters necessary for the synthesis of urea from ammonia (NH 3 , NH 4 + ). Absence of these enzymes or transporters results in the accumulation of toxic levels of ammonia in the blood and brain of affected patients. Glycerol phenylbutyrate oral liquid is a triglyceride containing 3 molecules of PBA.

PAA, the major metabolite of PBA, is the active moiety of glycerol phenylbutyrate oral liquid. PAA conjugates with glutamine (which contains 2 molecules of nitrogen) via acetylation in the liver and kidneys to form PAGN, which is excreted by the kidneys (Figure 1). On a molar basis, PAGN, like urea, contains 2 moles of nitrogen and provides an alternate vehicle for waste nitrogen excretion.

Figure 1: Glycerol Phenylbutyrate Oral Liquid Mechanism of Action fig. 1

📦 How Supplied / Storage and Handling 58 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Glycerol phenylbutyrate oral liquid 1.1 g/mL is supplied in multi-use, 25 mL glass bottles. The bottles are supplied in the following configuration: NDC 0480-3777-58: Single 25 mL bottle per carton Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Discard bottle 28 days after opening.

📋 Description 93 words ▾

11 DESCRIPTION Glycerol phenylbutyrate oral liquid is a clear, colorless to pale yellow oral liquid. It is insoluble in water and most organic solvents, and it is soluble in dimethylsulfoxide (DMSO) and greater than 65% acetonitrile. Glycerol phenylbutyrate is a nitrogen-binding agent.

It is a triglyceride containing 3 molecules of PBA linked to a glycerol backbone, the chemical name of which is benzenebutanoic acid, 1', 1' ' –(1,2,3-propanetriyl) ester with a molecular weight of 530.65. It has a molecular formula of C 33 H 38 O 6 . The structural formula is: structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Neurotoxicity [see Warnings and Precaut io ns ( 5.1 )] . Inform patients/caregivers that adverse reactions of glycerol phenylbutyrate oral liquid are sometimes the same as symptoms of high blood ammonia.

Neurological adverse reactions may also be associated with the major metabolite of glycerol phenylbutyrate oral liquid, PAA, and may be reversible. Blood tests for PAA may be done to measure the amount of PAA in the blood. Instruct the patient/caregiver to contact the healthcare provider immediately if the patient experiences: nausea, vomiting, headache, fatigue, somnolence, lightheadedness, confusion, exacerbation of preexisting neuropathy, disorientation, impaired memory, dysgeusia, or hypoacusis.

Pregnancy Report pregnancies to Teva at 1-888-838-2872 [see Use in Specific Populations ( 8.1 )] . Lactation Advise patients that breastfeeding is not recommended during treatment with glycerol phenylbutyrate oral liquid [see Use in Specific Populations ( 8.2 )] . Administration Instruct patients to take glycerol phenylbutyrate oral liquid with food or formula and to administer directly into the mouth via oral syringe.

Instruct patients to use the glycerol phenylbutyrate oral liquid bottle and oral syringe as follows: Use a new reclosable bottle cap adapter with each new bottle that is opened. Open the glycerol phenylbutyrate oral liquid bottle and twist on the new reclosable bottle cap adapter. Use a new and dry oral syringe to withdraw each prescribed dose of glycerol phenylbutyrate oral liquid.

Discard the oral syringe after each dose. Tightly close the tethered tab on the reclosable bottle cap adapter after each use. Do not rinse the reclosable bottle cap adapter.

Discard bottle and any remaining contents 28 days after opening. If water or moisture enters the glycerol phenylbutyrate oral liquid bottle, the contents will become cloudy in appearance. If the contents of the bottle appear cloudy at any time, do not use the remaining glycerol phenylbutyrate oral liquid in the bottle and return it to the pharmacy to be discarded.

Instruct that glycerol phenylbutyrate oral liquid should be administered just prior to breastfeeding in infants who are breastfeeding. Instruct patients to take glycerol phenylbutyrate oral liquid orally, even if they have a nasogastric and/or gastrostomy tube. For patients who cannot swallow and who have a nasogastric tube or gastrostomy tube in place, instruct patients/caregivers to administer glycerol phenylbutyrate oral liquid as follows: Utilize a new dry oral syringe to withdraw the prescribed dosage of glycerol phenylbutyrate oral liquid from the bottle.

Place the tip of the syringe into the gastrostomy/nasogastric tube. Utilizing the plunger of the syringe, administer glycerol phenylbutyrate oral liquid into the tube. Use a separate syringe to flush the nasogastric/gastrostomy tube.

Flush once with 10 mL of water or formula and allow the flush to drain. If needed, flush a second time with an additional 10 mL of water or formula to clear the tube. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Czech Republic By: Teva Czech Industries, s.r.o.

Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Iss. 3/2025

💬 Medication Guide ~3 min read ▾

Dispense with Medication Guide available at: www.tevausa.com/medguides MEDICATION GUIDE GLYCEROL PHENYLBUTYRATE (glis′ er ol fen′′ il bue′ ti rate) oral liquid What is the most important information I should know about glycerol phenylbutyrate oral liquid? Glycerol phenylbutyrate oral liquid may cause serious side effects, including: Nervous system problems (Neurotoxicity). Phenylacetate (PAA), a breakdown product of glycerol phenylbutyrate oral liquid, may cause nervous system side effects.

Call your doctor or get medical help right away if you get any of these symptoms while taking glycerol phenylbutyrate oral liquid: sleepiness lightheadedness change in taste problems with hearing confusion problems with memory worsening of numbness, tingling, or burning in your hands or feet headache feeling very tired (fatigue) nausea vomiting Your doctor may do blood tests to measure the amount of PAA in your blood during your treatment with glycerol phenylbutyrate oral liquid. What is glycerol phenylbutyrate oral liquid?

Glycerol phenylbutyrate oral liquid is a prescription medicine used for long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a urea cycle disorder (UCD). Glycerol phenylbutyrate oral liquid should be used if the UCD cannot be managed with a low protein diet and dietary supplements alone. Glycerol phenylbutyrate oral liquid must be used along with a low protein diet and in some cases dietary supplements.

Glycerol phenylbutyrate oral liquid is not used for the acute treatment of hyperammonemia in people with UCD. It is not known if glycerol phenylbutyrate oral liquid is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency. Do not take glycerol phenylbutyrate oral liquid if you are allergic to phenylbutyrate.

Call your doctor or go to the nearest hospital emergency room if you have wheezing, shortness of breath, cough, low blood pressure, flushing, nausea or a rash while taking glycerol phenylbutyrate oral liquid. Before taking glycerol phenylbutyrate oral liquid, tell your doctor about all of your medical conditions, including if you: have liver or kidney problems have pancreas or bowel (intestine) problems are pregnant or plan to become pregnant. It is not known if glycerol phenylbutyrate oral liquid will harm your unborn baby.

If you become pregnant during treatment with glycerol phenylbutyrate oral liquid, call Teva at 1-888-838-2872 to report the pregnancy. are breastfeeding or plan to breastfeed. It is not known if glycerol phenylbutyrate passes into your breast milk. Breastfeeding is not recommended during treatment with glycerol phenylbutyrate oral liquid.

Talk to your doctor about the best way to feed your baby if you take glycerol phenylbutyrate oral liquid. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Know the medicines you take.

Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take glycerol phenylbutyrate oral liquid? Take glycerol phenylbutyrate oral liquid exactly as your doctor tells you.

Your doctor will tell you how much glycerol phenylbutyrate oral liquid to take and when to take it. Your doctor may change your dose if needed. Take glycerol phenylbutyrate oral liquid with food or formula.

In an infant who is breastfeeding, give glycerol phenylbutyrate oral liquid just before breastfeeding. Glycerol phenylbutyrate oral liquid is an oral liquid that is taken by mouth using an oral syringe. Ask your pharmacist for oral syringes and a reclosable bottle cap adapter for each bottle you receive if you do not have them.

Use the glycerol phenylbutyrate oral liquid bottle and oral syringe as follows: Use a new reclosable bottle cap adapter with each new glycerol phenylbutyrate oral liquid bottle that is opened. Open the glycerol phenylbutyrate oral liquid bottle and twist on the new reclosab…

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 Glycerol Phenylbutyrate — the program that covers self-administered drugs. 2 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 Glycerol Phenylbutyrate. 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
$5.4M
Claims incl. refills
87
Beneficiaries
41
Spend / beneficiary
$131,820.43
Spend / claim
$62,122.27
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 ✓ Available
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 ✓ 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 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 Teva Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Teva Pharmaceuticals, Inc. 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.
← 00480-3720-01 · Teva 00480-4000-62 · Teva →
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.