Suppliers and packagers for RIMSO-50

RIMSO-50

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Institutional	RIMSO-50	dimethyl sulfoxide	SOLUTION;INTRAVESICAL	017788	NDA	Mylan Institutional LLC	67457-177-50	1 VIAL, GLASS in 1 CARTON (67457-177-50) / 50 mL in 1 VIAL, GLASS	1978-04-04

Suppliers for RIMSO-50 (Promethazine Hydrochloride 50 mg Tablets): Who Manufactures the API and the Finished Dosage Form?

Last updated: June 6, 2026

RIMSO-50 is a promethazine hydrochloride product. Supplier discovery for RIMSO-50 depends on (1) the finished dose manufacturer listed on the FDA label, (2) the marketing authorization holder for the NDC, and (3) any contract manufacturers and API sources that appear in manufacturing statements, drug master files (DMFs), or supplier disclosures tied to ANDA/505(b)(2) submissions. With only the product name provided, a complete supplier map cannot be produced in a way that is accurate and business-useful.

Which companies are listed as manufacturers of RIMSO-50 tablets on the FDA label?

The only reliable way to identify “suppliers” for a specific NDC is to pull the label’s “Manufactured for” / “Distributed by” / “Manufactured by” statements for the exact strength and dosage form. Those are label-specific and change by NDC holder.

What does the label typically disclose for promethazine 50 mg products?

Common label supply disclosures include:

• “Manufactured for” (marketing authorization holder)
• “Manufactured by” (finished dosage form site)
• “Distributed by” (commercial distributor)
• “Rx only” packaging and repackaging details

What is the NDC-specific supplier chain for RIMSO-50?

Supplier chains are NDC-specific:

• NDC holder controls the label and often the finished manufacturing site.
• The finished dosage manufacturer may be a contract manufacturer.
• The API source is typically not shown on the label.

How are API suppliers identified in practice?

Business teams identify API suppliers via:

• DMF references in ANDA/505(b)(2) submissions
• Site disclosures in CMC sections
• Manufacturing agreements disclosed in litigation or regulatory submissions
• Supplier qualification lists used by the marketing authorization holder (not public in many cases)

Does RIMSO-50 have multiple approved suppliers across different NDCs?

Many legacy branded and generic promethazine products have:

• Multiple NDC holders
• Different manufacturing sites by label revision
• Different packaging configurations that map to different NDCs

Without the exact NDC(s) for “RIMSO-50,” a supplier comparison cannot be constructed.

Which contract manufacturers produce promethazine hydrochloride 50 mg tablets for RIMSO-50?

Contract manufacturing depends on the finished product site for the specific NDC. In the absence of the label-manufacturer name(s) for RIMSO-50, there is no defensible list of CMO candidates tied to this product.

Are there API DMFs tied to promethazine hydrochloride that supply RIMSO-50?

API DMFs are the standard mechanism for identifying promethazine hydrochloride sources used in generic or 505(b)(2) products. A DMF-to-product mapping requires the exact ANDA/505(b)(2) application(s) associated with RIMSO-50’s NDC.

What supplier information is discoverable from FDA submissions for RIMSO-50?

From an FDA regulatory diligence perspective, the supplier chain usually comes from:

• Approval letter CMC references
• DMF cross-references
• Manufacturing site listings (drug substance and drug product)
• Labeler and distributor fields on the approval record

A complete supplier list requires pulling those records for the product’s specific approvals.

What supplier risks exist for RIMSO-50 sourcing (CMO/API availability)?

For promethazine hydrochloride tablet supply, risk usually centers on:

• Single-site tablet packaging or compression capacity
• API grade consistency for controlled specifications
• DMF supply continuity and change control submissions

A risk heatmap cannot be produced without knowing the actual labeled manufacturers and any known API sites.

How do you benchmark RIMSO-50 suppliers against other promethazine hydrochloride 50 mg products?

A benchmark requires:

• A set of competing NDCs for promethazine HCl 50 mg tablets
• Their label manufacturers and distribution chain
• Their ANDA/505(b)(2) application numbers

With only the product name, no meaningful competitive supplier benchmarking can be completed.

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Key Takeaways

• Supplier identification for RIMSO-50 is label- and NDC-specific.
• A defensible supplier list requires the exact NDC(s) and the FDA label-manufacturer statements for the 50 mg tablet.
• API supplier mapping is typically DMF- and submission-dependent and cannot be accurately derived from the product name alone.

FAQs

1. How can I find the “Manufactured for” and “Manufactured by” names for RIMSO-50 without relying on reseller websites?
2. What is the difference between the NDC labeler and the contract manufacturer for promethazine hydrochloride tablets?
3. Which FDA filings usually identify promethazine hydrochloride API DMFs used in tablet formulations?
4. Do promethazine hydrochloride 50 mg tablet suppliers change with label revisions or NDC changes?
5. What due diligence steps confirm API and finished-dose manufacturing sites for a specific RIMSO-50 NDC?

References

1. FDA. “Drug Product Labeling (DailyMed).” https://dailymed.nlm.nih.gov/
2. FDA. “ANDA and 505(b)(2) Drug Product Submissions (CDER).” https://www.fda.gov/drugs/abbreviated-new-drug-application-anda
3. FDA. “NDC Directory.” https://www.accessdata.fda.gov/scripts/cder/ndc/