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Suppliers and packagers for DILANTIN
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DILANTIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viatris | DILANTIN | phenytoin sodium | CAPSULE;ORAL | 084349 | ANDA | Viatris Specialty LLC | 58151-110-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01) | 2024-12-06 |
| Viatris | DILANTIN | phenytoin sodium | CAPSULE;ORAL | 084349 | ANDA | Viatris Specialty LLC | 58151-110-10 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-10) | 2024-12-06 |
| Viatris | DILANTIN | phenytoin sodium | CAPSULE;ORAL | 084349 | ANDA | Viatris Specialty LLC | 58151-110-88 | 100 BLISTER PACK in 1 CARTON (58151-110-88) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58151-110-32) | 2024-12-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for DILANTIN
What Is the Dilantin Supplier Landscape?
Dilantin is the brand name for phenytoin (phenytoin sodium). In the US, phenytoin generics and authorized generics are supplied by multiple manufacturers, with product availability shaped by FDA-approved ANDAs, authorized generics, and distribution contracts rather than by a single exclusive raw-material or finished-dose supplier.
Who Supplies Dilantin (Finished Product) in the Market?
Dilantin is marketed by Pfizer in the US (brand ownership), while generic phenytoin manufacturers supply most finished-dose demand through ANDAs. The supplier list changes over time with FDA approvals, labeling updates, and market allocation.
Finished-dose suppliers (market-facing)
- Brand holder: Pfizer (Dilantin brand)
- Generic and authorized-generic suppliers: multiple FDA ANDA holders for phenytoin sodium products across tablets and extended-release formulations, sold through wholesaler networks.
Product-form dependency
Dilantin’s “supplier” identity differs by dosage form and strength:
- Extended-release capsules/tablets (Dilantin type products) typically map to ANDAs for extended-release phenytoin
- Immediate-release products map to separate ANDA lines
In practice, when procurement teams say “Dilantin suppliers,” they often mean:
1) the brand channel (Pfizer) when they buy Dilantin, or
2) interchangeable generic phenytoin sources when they buy “Dilantin-equivalent.”
Which Companies Make FDA-Approved Generic Phenytoin (ANDA Suppliers)?
The legally operative supplier set is defined by FDA ANDA holders and their listed strengths, dosage forms, and labeling. The clean way to identify the active supplier roster for any given strength and dosage form is through FDA’s Drugs@FDA entry set for phenytoin sodium and the corresponding ANDA application holders.
How suppliers are determined in compliance terms
An ANDA holder is the company FDA lists as the marketing applicant/holder for the approved generic. This is the entity that controls labeling, manufacturing responsibility per submissions, and (typically) the supply chain routing.
What buyers can verify quickly
For any given Dilantin strength and dosage form, procurement teams normally verify:
- FDA application (ANDA) for phenytoin sodium (or extended-release variant)
- Applicant/holder name
- NDC-level labeling match to avoid strength/form mismatches
Who Supplies the Active Pharmaceutical Ingredient for Phenytoin Products?
Finished-dose suppliers are not the same as API suppliers. API sourcing typically splits into:
- API manufacturers listed in DMFs or through supplier declarations to the finished-dose applicant
- finished-dose manufacturers (ANDA holders), who may do secondary manufacturing, packaging, and release testing even if they do not synthesize the API
API supply chain structure (industry pattern)
For phenytoin, most market supply is handled through:
- specialty API manufacturers supplying phenytoin bulk drug substance to multiple finished-dose applicants
- finished-dose manufacturers that buy API or API-intermediate streams under qualification programs and then manufacture tablets/capsules
The API supplier roster is usually not visible at a single glance from retail market listings. It is typically traced through:
- FDA DMF references (if discoverable from the specific FDA application record), or
- supplier qualification documentation in buyer systems
What Are the Key Constraints That Affect Dilantin Availability and Supplier Substitution?
Dilantin supply and interchangeable sourcing are driven by:
- ANDA approval status per dosage form/strength
- manufacturing site capacity and stability
- distribution contracts with wholesalers and hospital group purchasing organizations
- labeling alignment (extended-release versus immediate-release)
Practical procurement implications
- Switching suppliers is usually feasible for generic phenytoin when labeling and dosage form match.
- Substituting across immediate-release vs extended-release can be clinically and label-dependent, so pharmacy and compliance workflows often require strict matching.
How Should Businesses Identify the Correct “Dilantin Supplier” for a Buy Decision?
Use this decision rule based on what is being procured:
If the order is for the brand “Dilantin”
- Supplier is Pfizer (brand market channel), unless the purchase is through an authorized channel that still distributes Pfizer-labeled Dilantin.
If the order is for “phenytoin sodium” equivalents
- Supplier is the ANDA holder corresponding to the NDC for the exact strength and dosage form.
- Procurement should validate:
- strength
- dosage form (extended-release vs immediate-release)
- labeling (including any rate/maintenance language)
- NDC match
Supplier List: What Can Be Stated Reliably From Public FDA Framework?
A complete, product-by-product supplier table for “Dilantin” in a specific strength and dosage form requires pulling the latest Drugs@FDA and Orange Book listings for the exact product configuration. Without those current record extracts, only the structural supplier model can be stated reliably:
| Supplier type | What it means in practice | Example entity class |
|---|---|---|
| Brand supplier | Company marketing the brand product | Pfizer (Dilantin) |
| Generic supplier (ANDA holder) | Company that holds/markets the approved generic | Multiple ANDA holders via FDA listings |
| API supplier | Company manufacturing phenytoin bulk drug substance | DMF-linked API manufacturers (not directly retail-visible) |
Key Takeaways
- Dilantin’s brand supplier is Pfizer, but the majority of “Dilantin-like” supply in the market comes from generic phenytoin ANDA holders.
- The “right supplier” depends on whether procurement targets brand Dilantin or interchangeable generic phenytoin, and on whether the product is extended-release vs immediate-release.
- Finished-dose suppliers are identified through FDA ANDA holders; API suppliers are identified through DMF-linked manufacturing networks, typically not visible from wholesaler listings alone.
FAQs
-
Is Pfizer the only supplier of Dilantin?
Pfizer is the brand marketer for Dilantin; other companies supply generic phenytoin products based on FDA-approved ANDAs. -
Do generic phenytoin suppliers always match Dilantin’s formulation?
No. Suppliers must be matched by strength and dosage form (notably extended-release vs immediate-release) to ensure label equivalence. -
Who supplies phenytoin API for finished-dose products?
API comes from specialty API manufacturers that supply bulk drug substance to finished-dose applicants; these suppliers are typically tied to DMFs and qualification documentation. -
How do you identify the current generic supplier for a specific phenytoin NDC?
Use the FDA Orange Book/Drugs@FDA record for the exact strength, dosage form, and NDC to identify the ANDA holder. -
Why do Dilantin suppliers appear to change over time?
Supplier visibility changes with ANDA approval activity, manufacturing capacity, distribution contracting, and NDC-level labeling updates.
References (APA)
[1] FDA. (n.d.). Drugs@FDA: Dilantin (phenytoin). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] FDA. (n.d.). FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (phenytoin sodium). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
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