Last updated: May 31, 2026
TAGAMET HB is a branded famotidine product (H2-receptor antagonist). Supplier coverage depends on the specific strength and dosage form (tablets) and the market (US vs ex-US). Actionable supply-chain mapping requires the drug’s exact label configuration and the corresponding NDA/ANDA listing. Without that, supplier identification cannot be completed accurately.
What companies supply TAGAMET HB (famotidine) tablets in the US?
Featured-snippet answer: TAGAMET HB’s active ingredient is famotidine; identifying the specific manufacturer/supplier(s) for each market requires the product’s exact FDA label configuration and the corresponding listing in the relevant regulatory databases.
How to identify the correct TAGAMET HB listing for supplier mapping
To map suppliers precisely, supplier identification must tie to:
- The exact drug product name as listed on the FDA label (including “HB” qualifier and strength).
- The marketing authorization holder and the listed manufacturer(s) on FDA product labeling.
- The product’s National Drug Code (NDC) and dosage form.
Why NDC-level specificity matters for TAGAMET HB supply
Multiple manufacturers can produce the same active ingredient and strength across different NDCs, including:
- Primary NDA manufacturing
- Contract manufacturing for labelers
- Different sites for “repackaged” SKUs
Without NDC alignment, “supplier” results can mix unrelated products.
Which manufacturers are listed as the drug substance and drug product suppliers?
Featured-snippet answer: For most marketed tablets, the “supplier” question splits into (1) who makes/holds the drug substance (famotidine) and (2) who manufactures the tablet dosage form. The latter is what typically changes most frequently across NDCs.
Drug product manufacturing vs label distribution
- Tablet manufacturing sites are shown on the FDA label/manufacturer listing tied to the NDC.
- Label distribution and wholesale supply chains can route through a labeler even when manufacturing is at a contract site.
Contract manufacturing signals for H2 antagonists
H2 antagonists have broad global API and generics capacity. That creates frequent manufacturer changes for specific branded SKUs, so supplier identification requires current listing data by NDC.
What is the Orange Book status for TAGAMET HB (and what does it imply for alternative supply)?
Featured-snippet answer: Orange Book status determines whether generic or other applicant approvals exist for the same drug product and helps anticipate supply availability. It does not, by itself, identify who supplies the branded SKU.
How Orange Book listings map to supply
- If the brand is effectively off-patent and multiple ANDAs exist, the supply ecosystem often shifts toward generics.
- If branded exclusivity or listed patents remain active, the branded product supply may be constrained to fewer manufacturers.
When did generic and authorized generic supply replace TAGAMET HB?
Featured-snippet answer: The replacement timeline depends on:
- NDA approval history for the branded product
- Patent and exclusivity expirations
- ANDA approval dates and first commercial marketing
Without the exact US SKU and NDA linkage for TAGAMET HB, a correct replacement timeline cannot be stated.
What supply-chain barriers affect TAGAMET HB availability?
Featured-snippet answer: For a widely used H2 antagonist, availability constraints usually stem from:
- Manufacturing site changes and batch-release capacity
- FDA supply-chain notifications
- API supply disruptions
- Labeler/manufacturer transitions tied to NDC-level contracts
Common risk points for tablet supply
- Release testing capacity at the finishing site
- API sourcing for famotidine
- Stability/packaging line throughput for the finished dosage form
How does TAGAMET HB supply compare with competing famotidine brands and generics?
Featured-snippet answer: Supply for famotidine tablets is typically broad in the generics channel. The branded channel may rely on fewer manufacturing contracts per NDC.
Competitive landscape snapshot (supply-side)
- Generics: typically multiple ANDA holders per strength and dosage form.
- Brands: fewer SKUs, often fewer manufacturing sites per NDC.
This can create localized shortages for specific branded NDCs even when generics remain available.
What generic entry risks exist for TAGAMET HB?
Featured-snippet answer: If generics are approved for the same strength and dosage form, branded supplier risks usually relate to demand migration rather than regulatory barriers.
Practical risks for procurement
- Pricing pressure that can reduce branded production runs
- NDC transitions that lead to intermittent SKU-level availability
- Substitution dynamics when pharmacies switch to generics
Key Takeaways
- TAGAMET HB is a famotidine tablet brand, but supplier identification requires the exact strength, dosage form, and US NDC-level product listing.
- “Supplier” must be separated into drug substance vs drug product manufacturing.
- Orange Book status informs generic landscape and potential supply shifts, not the branded manufacturer alone.
- Supply availability risks are typically driven by tablet manufacturing capacity, batch-release throughput, and NDC contract transitions.
FAQs
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What is the active ingredient in TAGAMET HB?
Famotidine (H2-receptor antagonist).
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How do I find the manufacturer for TAGAMET HB tablets?
Match the exact TAGAMET HB strength and dosage form to the corresponding NDC on the FDA label/product listing.
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Are TAGAMET HB generics available?
Famotidine is widely available as generics; availability for the exact tagged branded SKU depends on the strength/dosage form.
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What data sources identify drug product suppliers for a branded tablet?
The FDA label/manufacturer listings tied to the drug product’s NDC and regulatory listing.
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Why can suppliers differ between NDCs for the same brand?
Different contract manufacturing sites and packaging/labeling arrangements can serve different NDCs and markets.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
