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Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release shortage

Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release is currently listed in shortage by the FDA. The FDA lists 1 affected product. This page was last refreshed from FDA data on Oct 3, 2026.

To Be Discontinued ⚠ Supply risk: High Other 1 product 264 days First posted Jan 12, 2026 Updated Jan 12, 2026
Here’s the bottom line

Viatris is permanently stopping its generic doxylamine-pyridoxine delayed-release tablets (10 mg). The same 10 mg delayed-release tablet is still listed by other makers, including the brand Diclegis (doxylamine succinate and pyridoxine hydrochloride); Bonjesta, a higher-dose extended-release version, is also available from Duchesnay USA.

Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
1
Affected NDCs
1
Reporting manufacturers
0/1
Reporting mfrs supplying
0/1
Affected strengths supplied
264
Days in shortage
3,325
Medicaid Rx (2025)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Oct 3, 2026 · today

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
1 NDCs
To be discontinued 1
Affected strengths still supplied
Among manufacturers reporting this shortage
0/1 strengths
No supply 1
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
0/1 makers
No supply 1
✓ Other manufacturers not reporting a shortage
Still-marketed Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Actavis Pharma, Inc. Par Health USA, LLC Duchesnay USA, Inc. Bryant Ranch Prepack Bionpharma Inc., Analog Pharma
See all other options & details →
Shortage timeline
  1. Jan 12, 2026
    Currently in shortage
    1 of 1 product affected.
  2. Jan 12, 2026
    First reported to the FDA
    1 product first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Mylan Pharmaceuticals Inc., a Viatris Company 📞 800-796-9526 1 NDC click to expand
Status NDC / product Strength Availability Related information Reason
To Be Discontinued Doxylamine Succinate and Pyridoxine Hydrochloride, Tablet, Delayed Release, 10 mg; 10 mg (NDC 0378-4615-01) NDC 00378-4615-01 — — A business decision was made to discontinue manufacture of the drug. —

These rows are manufacturer reports to the FDA for Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release? options further down this page.

Why is Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release in shortage?

Mylan Pharmaceuticals (a Viatris company) has let the FDA know that they made a business decision to permanently stop making their version of doxylamine succinate and pyridoxine hydrochloride 10 mg / 10 mg delayed-release tablets (NDC 0378-4615-01). No specific reason beyond that business decision was shared publicly.

It's worth knowing that this report only covers Mylan's product — it doesn't mean every version of this medication is going away. Other manufacturers may still produce it and are listed separately. But as far as Mylan's tablets go, they will not be coming back.

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release?

Doxylamine succinate and pyridoxine (the delayed-release combination tablet, often used for nausea in pregnancy) is currently on the FDA shortage list. Please know that this affects one manufacturer's product — it does not mean the medicine has disappeared from every maker.

The strength involved is the 10 mg / 10 mg delayed-release tablet made by Mylan (a Viatris company). This specific product has no available source right now. The company reports this is because of a business decision to discontinue manufacturing it, which means this particular version is being permanently stopped rather than temporarily out of stock.

Because this is a discontinuation, the most important step is to plan ahead calmly with your care team. Here is what I suggest:

  • Do not stop, skip, or change your dose on your own.
  • The same medicine (doxylamine 10 mg / pyridoxine 10 mg, delayed-release) is still made by other companies, including Actavis, Par Health, Bionpharma, Analog Pharma, and Bryant Ranch. Ask your pharmacy whether they can order one of these — though it may not be in local stock today.
  • Talk with your prescriber or pharmacist about the best path forward for you.

Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls. This is general, national information and may not match your local pharmacy's actual stock.

See “Where else can I get Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Keep reading
Our full Doxylamine and Pyridoxine guide

Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.

Read the Doxylamine and Pyridoxine guide →

Where else can I get Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Doxylamine Succinate And Pyridoxine Hydrochloride DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg/1 Tablet, Delayed Release · Oral Actavis Pharma, Inc. 00591-2132-01
Doxylamine Succinate And Pyridoxine Hydrochloride DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg/1 Tablet, Delayed Release · Oral Par Health USA, LLC 49884-0186-01
Diclegis DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg/1 Tablet, Delayed Release · Oral Duchesnay USA, Inc. 55494-0100-10
Bonjesta DOXYLAMINE SUCCINATE 20 mg/1; PYRIDOXINE HYDROCHLORIDE 20 mg/1 Tablet, Extended Release · Oral Duchesnay USA, Inc. 55494-0120-10
Doxylamine Succinate And Pyridoxine Hydrochloride DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg/1 Tablet, Delayed Release · Oral Bryant Ranch Prepack 63629-2184-01
Doxylamine Succinate And Pyridoxine Hydrochloride DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg/1 Tablet, Delayed Release · Oral Bionpharma Inc., 69452-0206-20
Doxylamine Succinate And Pyridoxine Hydrochloride DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg/1 Tablet, Delayed Release · Oral Analog Pharma 70505-0100-10
Therapeutic equivalents & pricing 8 productsclick to expand

Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Doxylamine succinate and pyridoxine hydrochloride 10 mg/1; 10 mgNDC 00591-2132-01 Actavis 100 tablets $1.092 save 14% AB Availability likely
Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mgNDC 49884-0186-01 Par 100 tablets $1.092 save 14% AB Availability likely
Doxylamine succinate and Pyridoxine hydrochloride 10 mg/1; 10 mgNDC 69452-0206-20 Bionpharma 100 tablets $1.092 save 14% AB Availability likely
Doxylamine succinate and pyridoxine hydrochloride 10 mg/1; 10 mgNDC 70505-0100-10 Analog 100 tablets $1.092 save 14% AB Availability likely
Doxylamine Succinate and Pyridoxine Hydrochloride 10; 10 mg/1; mgNDC 00378-4615-01 Mylan 100 tablets $1.263 — Discontinued
Diclegis 10 mg/1; 10 mgNDC 55494-0100-10 Duchesnay 100 tablets $1.676 +33% AB Availability likely
Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mgNDC 63629-2184-01 Bryant 100 tablets — AB FDA listed
Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mgNDC 72162-1485-01 Bryant 100 tablets — AB FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Other drugs in the same treatment class

These are different medicines — not other versions of Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release — that fall in the same broad treatment class (antiemetic/antivertigo agents) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.

Identity & classification

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
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Other other shortages

Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release shortage FAQs

Is Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release in shortage?
Yes — the FDA currently lists Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release in shortage (status: “To Be Discontinued”, first reported Jan 12, 2026). 1 of 1 product is affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Which products are affected?
Doxylamine Succinate and Pyridoxine Hydrochloride, Tablet, Delayed Release, 10 mg; 10 mg (NDC 0378-4615-01) (NDC 00378-4615-01). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release be available again?
The FDA does not publish a guaranteed restock date, and no estimated-recovery note is on file. Availability can change daily — confirm with your pharmacy.
Can I still get Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release somewhere?
Other manufacturers (Actavis Pharma, Inc., Par Health USA, LLC, Duchesnay USA, Inc. and others) still market it and have not reported a shortage. See “Where else can I get Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release?” above — stock still varies by pharmacy.
What should I do if I take Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out.

Still have a question about the Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release shortage?

Ask a pharmacist about this shortage →
How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
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