Doxylamine Succinate and Pyridoxine Hydrochloride 10; 10 mg; mg Tablet, Delayed Release, 100-count
by Mylan Pharmaceuticals Inc. · 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01)
NDC 00378-4615-01
🏷️ FDA NDC (as labeled)
0378-4615-01
billing pads the labeler segment with a zero
Rx only
Generic
Discontinued
Non-controlled
⚠ On shortage
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Active FDA shortage. Doxylamine Succinate and Pyridoxine Hydrochloride Tablet, Delayed Release is currently reported in shortage by the FDA. Shortage details →
⚠️
Other active recalls for Doxylamine Succinate And Pyridoxine 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 III · Aug 7, 2026 — Presence of Foreign Tablets/Capsules (Bionpharma Inc.) · FDA recall D-0822-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through May 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
0378-4615-01
Product NDC
0378-4615
11-digit billing NDC
00378461501
NCPDP billing unit
EA — each (per item)
Application #
ANDA207825
Established class (EPC)
Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through May 2026)
Route
ORAL
Dosage form
TABLET, DELAYED RELEASE
Substance
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
GCN Seq No
004722
GCN
73860
HICL code
001970
Ingredient (HICL)
Doxylamine Succinate/Vit B6
HIC1 code
H
Therapeutic class — broad (HIC1)
Nervous System (Except Autonomic)
HIC2 code
H6
Therapeutic class — intermediate (HIC2)
Drugs Acting Principally On The Midbrain
HIC3 code
H6J
Therapeutic class — specific (HIC3)
Antiemetic/Antivertigo Agents
AHFS code
48:04.04.00
AHFS class
First Generation Antihist.(Respir Tract)
FDB label name
DOXYLAMINE-PYRIDOXINE 10-10 MG
FDB brand name
Doxylamine Succ-Pyridoxine Hcl
Legend status
F — Federal legend — prescription drug or device
Why two NDCs?
The FDA registers this code as 0378-4615-01 — 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 → 00378-4615-01. 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
LabelerMylan Pharmaceuticals Inc.
Application holderPHARMOBEDIENT CONSULTING LLC
FDA applicationANDA207825 (ANDA)
Labeler code00378
Product typeHuman Prescription Drug
Portfolio473 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 DOXYLAMINE-PYRIDOXINE 10-10 MG Ingredient Doxylamine Succinate/Vit B6
📖 What it is MedlinePlus · NLM
The combination of doxylamine and pyridoxine is used to treat nausea and vomiting in pregnant women . Doxylamine is in a class of medications called antihistamines. It works by blocking the action of certain natural substances in the body that may contribute to nausea and vomiting. Pyridoxine (vitamin B6) is a vitamin. A lack of pyridoxine in the body may also be a factor in causing nausea and vomiting during pregnancy.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Yes — this is the only FDA-approved oral medication specifically indicated for nausea and vomiting of pregnancy. Multiple large studies, including meta-analyses covering tens of th...
- Is this medication actually safe to take during pregnancy?
- Food can significantly reduce how much of the pyridoxine (vitamin B6) component your body actually absorbs — in some studies by around 50%. It also delays when the medication start...
- Why do I have to take it on an empty stomach?
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 doxylamine succinate and pyridoxine hydrochloride?
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.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.263 | $126.27 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $1.44 | $144.38 / 100 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per ea) — tap or hover for the price & month
▼ Down 58% over the last 21 months.
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 |
|---|---|---|---|---|---|---|
| Doxylamine succinate and pyridoxine hydrochloride 10 mg/1; 10 mg 00591-2132-01 | Actavis | 100 tablets | $1.145 | AB | Availability likely | save 9% |
| Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mg 49884-0186-01 | Par | 100 tablets | $1.145 | AB | Availability likely | save 9% |
| Doxylamine succinate and Pyridoxine hydrochloride 10 mg/1; 10 mg 69452-0206-20 | Bionpharma | 100 tablets | $1.145 | AB | Availability likely | save 9% |
| Doxylamine succinate and pyridoxine hydrochloride 10 mg/1; 10 mg 70505-0100-10 | Analog | 100 tablets | $1.145 | AB | Availability likely | save 9% |
| Doxylamine Succinate and Pyridoxine Hydrochloride 10; 10 mg/1; mgthis 00378-4615-01 | Mylan | 100 tablets | $1.263 | — | Discontinued | — |
| Diclegis 10 mg/1; 10 mg 55494-0100-10 | Duchesnay | 100 tablets | $1.671 | AB | Availability likely | +32% |
| Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mg 63629-2184-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mg 72162-1485-01 | Bryant | 100 tablets | — | 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
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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00378-4615-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.3K
Units reimbursed last 4 qtrs
226.1K
Gross reimbursed last 4 qtrs
$326.4K
Avg / prescription
$98.17
Avg / unit
$1.4438
Latest quarter Q4 2025
177Rx
Medicaid pays / ea
$1.4438
gross reimbursed
vs
NADAC / ea
$1.2627
acquisition cost
=
Spread
+$0.1811
+14% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 2,210 Rx Managed care · 1,115 Rx
State Medicaid map
Units reimbursed · per 100k residents
2.5758
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
🔬 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 Doxylamine succinate and Pyridoxine hydrochloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 6%
Female · 94%
Unknown · 0%
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 |
|---|---|---|---|
| 00378-4615-01 You're viewing this | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01) | 2020-07-21 | Discontinued by firm |
🧭 About this NDC listing & data coverage
Finished prescription product
No longer marketed (per FDA listing data)
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| Package photos | — Not published for this NDC The FDA label for this product carries no photos. |
| 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) | ✓ Available |
| 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) | ✓ Available |
“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 full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0378-4615-01, 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: 00378-4615-01, written without dashes as 00378461501. 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 00378-4615-01, the first segment (00378) is the labeler code FDA assigned to Mylan Pharmaceuticals Inc.; the middle segment (4615) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Mylan 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.
📄 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.
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.