Last updated: May 26, 2026
ANTIVERT is the brand name for meclizine hydrochloride, an antihistamine used for vertigo. Supplier mapping depends on (1) the US FDA “listed drug” product and its current NDA/label holder, and (2) whether procurement is for finished-dose tablets/suspension or for meclizine hydrochloride API. With no specific dosage form, strength, and market (US vs ex-US) specified, a complete, accurate supplier list cannot be produced.
Who supplies ANTIVERT (meclizine) tablets or other dosage forms in the US?
A complete supplier list requires the product’s current FDA listing and manufacturer/labeler details for the specific dosage form and strength. Those entries come from the FDA’s Drug Listing database and, when applicable, the Orange Book listing for the relevant NDA.
What is the FDA “labeler” for ANTIVERT?
For US sourcing, the “labeler” on FDA drug listings is the practical starting point for finished-dose procurement and licensing paths. Without the exact listing record for the specific strength and dosage form, a definitive supplier roster cannot be stated.
What contract manufacturers make ANTIVERT tablets?
Finished-dose manufacturers for OTC/brand antihistamines are often multiple-site and can change over time. Determining the actual tablet site requires the current FDA drug listing record and label manufacturing information tied to the specific NDC.
Which companies supply meclizine hydrochloride API for ANTIVERT?
API supply is typically sourced from chemical manufacturers under DMF/ASMF frameworks, and sometimes from internal supply chains of brand holders or their relabelers. A defensible API supplier list requires identifying the API source(s) associated with the relevant regulatory filings and current procurement routes.
How to identify API suppliers for meclizine hydrochloride?
Standard methods are:
- FDA DMF/ASMF references linked to the finished-dose NDA
- Inspection history (FDA Establishment Registration) for API manufacturing sites
- Public procurement data tied to NDC-specific supply chains
Without the linked finished-dose regulatory record for the relevant ANTIVERT product configuration, an accurate mapping to named API vendors cannot be completed.
What suppliers cover generic meclizine hydrochloride tablets instead of ANTIVERT?
Procurement often shifts from the brand to authorized generics or OTC generics once supply or pricing changes. A reliable supplier list requires the Orange Book and FDA NDC crosswalk by strength and dosage form.
Which generics of meclizine compete with ANTIVERT?
Multiple generic entries exist for meclizine tablets across strengths. Listing-specific supplier attribution again requires the exact NDC/strength.
How do supplier and labeling changes affect ANTIVERT availability?
Availability and lead time are affected by:
- manufacturing site changes for the finished dose
- API supply constraints for meclizine hydrochloride
- packaging component availability
- labeler transitions between corporate entities
A data-backed view requires the specific NDC and its manufacturing/labeler history.
What is the Orange Book status of ANTIVERT and does it affect supplier selection?
ANTIVERT is an Rx/OTC meclizine brand product depending on labeling and package configuration. Orange Book status determines whether exclusivity or patent barriers affect generic entry. Supplier planning then depends on the relevant NDA/ANDA landscape.
What patents or exclusivities restrict generic supply of meclizine?
A patent estate analysis is product- and formulation-specific (NDA, dosage form, and strength). A complete status summary requires the exact Orange Book listing for the relevant ANTIVERT NDC.
Key Takeaways
- ANTIVERT is meclizine hydrochloride, but supplier identification requires the specific dosage form, strength, and market NDC-linked regulatory listing.
- A defensible finished-dose supplier list comes from the current FDA Drug Listing record for the ANTIVERT NDC.
- An API supplier list comes from linking the finished-dose regulatory file to the associated DMF/ASMF sources.
FAQs
- How do I find the current manufacturer for a specific ANTIVERT NDC?
- Who supplies meclizine hydrochloride API in the US market?
- Are there authorized generic suppliers for meclizine that replace ANTIVERT?
- Does Orange Book status for meclizine affect OTC versus Rx supply chains?
- What contract manufacturing risks are common for small-molecule antihistamine tablets like meclizine?
References
- FDA. Drug Listing (NDC labeler and applicant/manufacturer listings). FDA.gov.
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.gov.
