dicyclomine hydrochloride 10 mg Capsule, 1,000-count
by Hikma Pharmaceuticals USA Inc. · 1000 CAPSULE in 1 BOTTLE, PLASTIC (0054-0883-31)
NDC 00054-0883-31
🏷️ FDA NDC (as labeled)
0054-0883-31
billing pads the labeler segment with a zero
This package
Contains1,000-count
Pack sizes2 compare ↓
Also comes in:
100 capsules 00054-0883-25
Rx only
Generic
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 →
⚠️
Other active recalls for Dicyclomine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 23, 2026 — shortfill; reports of empty capsules. (Aurobindo Pharma USA Inc) · FDA recall D-0733-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
0054-0883-31
Product NDC
0054-0883
11-digit billing NDC
00054088331
Application #
ANDA040204
SPL Set ID
708bcd61-8737-40fa-8970-08fc0f719f83
Established class (EPC)
Anticholinergic
Mechanism of action
Cholinergic Antagonists
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-09-15
Route
ORAL
Dosage form
CAPSULE
Substance
DICYCLOMINE HYDROCHLORIDE
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 0054-0883-31 — 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 → 00054-0883-31. 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
LabelerHikma Pharmaceuticals USA Inc.
Application holderWEST WARD PHARMACEUTICAL CORP
FDA applicationANDA040204 (ANDA)
Labeler code00054
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio726 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
📗 Our plain-language guide HelloPharmacist
- Dicyclomine relaxes the overactive muscles in your intestines that cause IBS cramping and pain — it works both by blocking certain nerve signals and by directly calming the gut mus...
- What exactly does dicyclomine do, and how quickly will I notice it working?
- The most common ones are dizziness, dry mouth, and blurred vision — these showed up in a significant number of patients in clinical trials. You might also notice some nausea, drows...
- What are the most common side effects I should expect?
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 dicyclomine hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
Blue
ShapeCapsule
ImprintWest;ward;3126
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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 H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
-
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
-
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
9 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 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.
Try another pack size:
100 capsules
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 |
|---|---|---|---|---|---|---|
| Dicyclomine hydrochloride 10 mg 00054-0748-25 | Hikma | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine hydrochloride 10 mg 43547-0634-10 | Solco | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 59651-0719-01 | Aurobindo | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 16571-0260-01 | Rising | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 00904-6987-61 | Major | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 60687-0369-01 | American | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 50268-0199-15 | AvPAK | 50 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 62135-0718-90 | Chartwell | 90 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 73473-0800-01 | Solaris | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 24979-0201-01 | Upsher-Smith | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 00527-0586-01 | Lannett | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine hydrochloride 10 mg 31722-0052-01 | Camber | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine hydrochloride 10 mg 00832-6053-10 | Upsher-Smith | 1000 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 00591-0794-01 | Actavis | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 71610-0265-09 | Aphena | 9000 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 50090-0127-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 51407-0783-01 | Golden | 100 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 71205-0428-15 | Proficient | 15 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 71335-0938-01 | Bryant | 30 capsules | — | AB | Discontinued | — |
| Dicyclomine Hydrochloride 10 mg 42708-0160-56 | QPharma, | 56 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 72162-2613-00 | Bryant | 1000 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 50090-7729-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 67296-2158-03 | Redpharm | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 70518-4432-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 00615-8483-39 | NCS | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 50090-7341-01 | A-S | 28 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 66267-0291-30 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 72789-0522-01 | PD-Rx | 100 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 55289-0923-20 | PD-Rx | 20 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 63187-0196-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 43063-0112-04 | PD-Rx | 4 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 43063-0629-28 | PD-Rx | 28 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 50090-7340-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 55154-8183-00 | Cardinal | 10 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 70518-4331-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 71335-0471-01 | Bryant | 30 capsules | — | AB | Discontinued | — |
| Dicyclomine Hydrochloride 10 mg 72789-0546-28 | PD-Rx | 28 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 68071-3674-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 71335-9709-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 68071-3310-01 | NuCare | 16 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 50090-0126-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 51655-0219-27 | Northwind | 12 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 67046-1513-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 55154-3565-00 | Cardinal | 10 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 68071-3035-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 68788-8578-01 | Preferred | 100 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 71335-2316-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 55700-0766-30 | Quality | 30 capsules | — | AB | Discontinued | — |
| Dicyclomine Hydrochloride 10 mg 67046-1258-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 72888-0105-00 | Advagen | 1000 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 67296-2310-03 | Redpharm | 30 capsules | — | AB | FDA listed | — |
| dicyclomine hydrochloride 10 mgthis 00054-0883-31 | Hikma | 1000 capsules | — | AB | FDA listed | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dicyclomine hydrochloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00054-0883-25 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0883-25) | 2026-09-15 | Active |
| 00054-0883-31 You're viewing this | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0054-0883-31) | 2026-09-15 | Active |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 00054-0883-31?
NDC 00054-0883-31 is a 1,000-count package — 1000 capsule in 1 bottle, plastic.
What is the difference between NDC 00054-0883-31 and NDC 00054-0883-25?
Both are dicyclomine hydrochloride 10 mg Capsule — the drug itself is identical. NDC 00054-0883-31 is the 1,000-count package, while NDC 00054-0883-25 is the 100 capsules package.
What NDC number is used to bill for this package of dicyclomine hydrochloride 10 mg Capsule?
Bill NDC 00054-0883-31 — the 11-digit billing format is 00054088331. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 0054-0883-31, 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: 00054-0883-31, written without dashes as 00054088331. 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 00054-0883-31, the first segment (00054) is the labeler code FDA assigned to Hikma Pharmaceuticals USA Inc.; the middle segment (0883) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) 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 Hikma Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 capsules (00054-0883-25). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Hikma Pharmaceuticals USA 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.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
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.