Data / Drug companies / H2-Pharma, LLC
H2-Pharma, LLC: 50 products in the FDA NDC directory, labeler code 61269
H2-Pharma, LLC (labeler code 61269) lists 50 products in the FDA National Drug Code Directory, covering 16 finished drugs by generic name. By type: 43 prescription drugs, 7 over the counter drugs. Its main marketing category is new drug applications (NDA). The newest product started marketing on August 4, 2026.
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- Labeler code
- 61269
- Products in commercial distribution
- 50
- Packages
- 52
- Finished drugs by generic name
- 16
- Prescription products
- 43
- Over the counter products
- 7
- Controlled substance products
- Schedule IV 3
- Flagged as original packager
- 36 of 36 products that carry the flag
- Started marketing in the last 12 months
- 1
- Products with a marketing end date set
- 2
- Earliest marketing start
- June 2, 1975
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 41 | 82% |
| Generic drugs (ANDA) | 7 | 14% |
| Authorized generics (NDA) | 2 | 4% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 43 | 86% |
| Over the counter drugs | 7 | 14% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Olanzapine | 11 | 49 |
| Quetiapine | 11 | 30 |
| Hydroxyurea | 4 | 14 |
| Clonazepam | 3 | 36 |
| Olanzapine pamoate | 3 | 1 |
| Budesonide | 2 | 40 |
| Orlistat | 2 | 3 |
| Miconazole nitrate | 2 | 101 |
| Docosanol | 2 | 42 |
| Valganciclovir | 1 | 14 |
| Etoposide phosphate | 1 | 1 |
| Valganciclovir hydrochloride | 1 | 11 |
| Omeprazole | 1 | 106 |
| Clotrimazole | 1 | 98 |
| Fexofenadine hydrochloride | 1 | 65 |
| Capecitabine | 1 | 19 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 9 | 18% |
| Capsule | 9 | 18% |
| Tablet, film coated | 8 | 16% |
| Tablet, extended release | 5 | 10% |
| Cream | 5 | 10% |
| Tablet, orally disintegrating | 4 | 8% |
| Kit | 3 | 6% |
| Aerosol, powder | 2 | 4% |
| Injection, powder, lyophilized, for solution | 1 | 2% |
| Powder, for solution | 1 | 2% |
| Injection, powder, for solution | 1 | 2% |
| Tablet, delayed release | 1 | 2% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Omeprazole Delayed release | 61269-720 | Tablet, delayed release | Generic drugs (ANDA) | August 4, 2026 |
| Pylera | 61269-381 | Capsule | New drug applications (NDA) | August 18, 2025 |
| Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride | 61269-386 | Capsule | Authorized generics (NDA) | July 1, 2025 |
| Docosanol | 61269-881 | Cream | Generic drugs (ANDA) | April 10, 2025 |
| Pylera | 61269-380 | Capsule | New drug applications (NDA) | October 1, 2023 |
| Docosanol | 61269-989 | Cream | Generic drugs (ANDA) | July 18, 2023 |
| Childrens Allergy | 61269-527 | Suspension | Generic drugs (ANDA) | July 18, 2022 |
| Orlistat | 61269-565 | Capsule | Authorized generics (NDA) | June 1, 2022 |
| Clotrimazole | 61269-220 | Cream | Generic drugs (ANDA) | June 29, 2021 |
| Miconazole 7 | 61269-730 | Cream | Generic drugs (ANDA) | April 12, 2021 |
| Miconazole 7 | 61269-730 | Cream | Generic drugs (ANDA) | March 15, 2021 |
| Xenical | 61269-460 | Capsule | New drug applications (NDA) | December 17, 2010 |
| ZYPREXA Relprevv | 61269-662 | Kit | New drug applications (NDA) | December 11, 2009 |
| ZYPREXA Relprevv | 61269-661 | Kit | New drug applications (NDA) | December 11, 2009 |
| ZYPREXA Relprevv | 61269-660 | Kit | New drug applications (NDA) | December 11, 2009 |
| Valcyte | 61269-485 | Powder, for solution | New drug applications (NDA) | August 28, 2009 |
| Hydrea | 61269-835 | Capsule | New drug applications (NDA) | June 1, 2009 |
| Etopophos | 61269-410 | Injection, powder, lyophilized, for solution | New drug applications (NDA) | June 1, 2009 |
| Droxia | 61269-404 | Capsule | New drug applications (NDA) | June 1, 2009 |
| Droxia | 61269-403 | Capsule | New drug applications (NDA) | June 1, 2009 |
| Droxia | 61269-402 | Capsule | New drug applications (NDA) | June 1, 2009 |
| Seroquel xr | 61269-271 | Tablet, extended release | New drug applications (NDA) | February 1, 2009 |
| Seroquel xr | 61269-270 | Tablet, extended release | New drug applications (NDA) | February 1, 2009 |
| Seroquel xr | 61269-274 | Tablet, extended release | New drug applications (NDA) | July 16, 2007 |
| Seroquel xr | 61269-273 | Tablet, extended release | New drug applications (NDA) | July 16, 2007 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.