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Suppliers and packagers for ZEGERID OTC
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ZEGERID OTC
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 022281 | NDA | Riley Consumer Care LLC | 82632-100-01 | 1 BOTTLE in 1 CARTON (82632-100-01) / 14 CAPSULE in 1 BOTTLE | 2024-03-01 |
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 022281 | NDA | Riley Consumer Care LLC | 82632-100-03 | 1 BOTTLE in 1 CARTON (82632-100-03) / 42 CAPSULE in 1 BOTTLE | 2024-03-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for ZEGERID OTC
ZEGERID OTC Suppliers: Who Makes the Omeprazole + Sodium Bicarbonate Products, Contract Manufacturing, and Upstream Packaging Partners
ZEGERID OTC (omeprazole magnesium with sodium bicarbonate; OTC proton pump inhibitor) is supplied through a mix of branded manufacturer supply chains and downstream contracted manufacturing and packaging. The precise supplier roster depends on the specific dosage form sold (capsules vs. tablets), strength, and lot-level labeling.
No complete, source-backed supplier map (name-by-name upstream API, blend, bulk drug product, packaging, and private-label partners) is available in the information provided, so no definitive supplier list can be produced without risking inaccuracies.
What companies supply ZEGERID OTC (omeprazole + sodium bicarbonate) in the US?
Answer: A definitive, fully enumerated list of upstream and downstream suppliers for ZEGERID OTC cannot be stated from the available input.
Which supplier roles matter for ZEGERID OTC
ZEGERID OTC supply chains typically split into:
- API supplier: omeprazole (usually from multiple global sources)
- Alkalizer component supplier: sodium bicarbonate (often multiple commodity suppliers)
- Drug product manufacturing: granulation, blending, encapsulation/tabletting, and fill-finish
- Packaging and labeling: bottle/strip packaging, cartonization, and label printing
What label and listing signals identify suppliers
In US distribution, the most reliable signals come from:
- FDA Orange Book “Manufactured for” / “Labeler” fields (for drug product and NDA/BLA labeling)
- GMP inspection databases (for sites manufacturing the listed products)
- Lot/package labeling on-shelf (for actual packager, releaser, and sometimes manufacturer identifiers)
How do you identify the actual ZEGERID OTC manufacturer on the product label?
Answer: The manufacturer and packager are usually specified by the “manufactured for” or “distributed by” line, plus the labeler of record. Without the product label text or the FDA listing record for the specific strength and dosage form, a definitive name cannot be compiled.
Dosage-form and strength differences
ZEGERID OTC exists in marketed forms that can have different labeler/manufacturer relationships:
- Capsules (omeprazole + sodium bicarbonate)
- Tablets (where marketed under the same brand umbrella)
- Strength-dependent labeler variations across distribution cycles
Which contract manufacturers make ZEGERID OTC?
Answer: A named contract-manufacturer list cannot be produced from the available information.
Common ways contract manufacturing is documented
- FDA drug product site associated with the NDA listing labeler
- Inspection data mapping an establishment number to a manufacturer for the finished dose form
- DMF references for formulation and processing inputs (when tied to the drug product)
What is the Orange Book status of ZEGERID OTC, and what does it imply about suppliers?
Answer: The Orange Book status cannot be confirmed from the available input, so supplier implications tied to the listed NDA and product/manufacturing entries cannot be stated.
What to extract from Orange Book for supplier mapping
For each strength/dosage form, Orange Book entries typically provide:
- NDA number
- Labeler name
- Dosage form
- Route of administration
- Patent and exclusivity (if applicable)
- Manufacturing site details (where available via linked establishment listings or inspection mapping)
Who supplies omeprazole APIs used in ZEGERID OTC?
Answer: A definitive supplier roster for the omeprazole API used in ZEGERID OTC cannot be stated without specific sourcing/DMF linkage or confirmed labeler site mapping.
Why API supplier attribution is non-trivial
- Omeprazole is a widely sourced API.
- Finished dose suppliers can blend supply lots across multiple approved sites.
- API supplier details are not always exposed in public Orange Book fields.
What upstream raw material suppliers provide sodium bicarbonate for ZEGERID OTC?
Answer: No definitive raw-material supplier list can be stated from the available input.
Commodity input reality
Sodium bicarbonate is generally procured from multiple commodity and specialty suppliers. Contract terms and substitution rules can vary by lot and finished-goods site.
Where can ZEGERID OTC be manufactured, packed, and released?
Answer: Manufacturing geography and packager/releaser identities cannot be enumerated without:
- establishment-to-product mapping data for the specific dosage form/strength, or
- the exact FDA listing entries and the referenced manufacturing establishments.
How does ZEGERID OTC supply compare with Nexium OTC or Prilosec OTC suppliers?
Answer: A direct supplier comparison cannot be completed from the available input because supplier identities for ZEGERID OTC are not established here, and corresponding supplier lists for competitors are also not provided.
Key Takeaways
- ZEGERID OTC supply is determined by dosage-form/strength-specific labeler and manufacturing establishment entries.
- A fully enumerated, name-by-name supplier list (API, drug product contract manufacturer, packaging/labeling) cannot be produced from the information provided.
- The most reliable public pathway for supplier mapping is Orange Book labeler/manufacturing entries combined with establishment-level GMP inspection records and lot-level labeling.
FAQs
-
How do I confirm the manufacturer of ZEGERID OTC capsules sold in my market?
Check the “manufactured for”/labeler line on the bottle and match it to the corresponding FDA drug product listing for that strength. -
Are ZEGERID OTC suppliers the same across all strengths?
Often not. Labeler and manufacturing sites can vary by strength and packaging configuration. -
Can I trace ZEGERID OTC production sites using FDA inspection records?
Yes, when you identify the establishment numbers tied to the marketed product and packaging configuration. -
Does ZEGERID OTC use a single omeprazole API supplier?
Most likely not. API supply is commonly multi-sourced across approved manufacturing sites. -
Do packaging suppliers change for ZEGERID OTC over time?
Yes. Contract packaging partners can rotate based on capacity, regional distribution needs, and lot-level requirements.
References (APA)
- No sources were provided in the prompt to cite.
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