Data / Drug companies / Gland Pharma Limited
Gland Pharma Limited: 275 products in the FDA NDC directory, labeler code 68083
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Gland Pharma Limited (labeler code 68083) lists 275 products in the FDA National Drug Code Directory, covering 136 finished drugs by generic name. By type: 268 prescription drugs, 4 over the counter drugs. Its main marketing category is generic drugs (ANDA). The newest product started marketing on November 2, 2026.
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- Labeler code
- 68083
- Products in commercial distribution
- 275
- Packages
- 297
- Finished drugs by generic name
- 136
- Prescription products
- 268
- Over the counter products
- 4
- Controlled substance products
- Schedule III 4, Schedule IV 4, Schedule V 1
- Flagged as original packager
- 253 of 253 products that carry the flag
- Started marketing in the last 12 months
- 27
- Earliest marketing start
- September 25, 2009
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 272 | 98.9% |
| Export only | 2 | 0.7% |
| Bulk ingredients for compounding | 1 | 0.4% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 268 | 97.5% |
| Over the counter drugs | 4 | 1.5% |
| Bulk ingredients | 3 | 1.1% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 91 | 33.1% |
| Injection | 89 | 32.4% |
| Injection, powder, lyophilized, for solution | 44 | 16% |
| Solution/ drops | 26 | 9.5% |
| Solution | 11 | 4% |
| Injection, suspension | 5 | 1.8% |
| Kit | 3 | 1.1% |
| Injection, solution, concentrate | 3 | 1.1% |
| Solution, gel forming / drops | 2 | 0.7% |
| Injection, emulsion | 1 | 0.4% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Methylprednisolone Acetate | 68083-622 | Injection, suspension | Generic drugs (ANDA) | November 2, 2026 |
| Methylprednisolone Acetate | 68083-621 | Injection, suspension | Generic drugs (ANDA) | November 2, 2026 |
| Methylprednisolone Acetate | 68083-620 | Injection, suspension | Generic drugs (ANDA) | November 2, 2026 |
| Methylprednisolone acetate | 68083-617 | Injection, suspension | Generic drugs (ANDA) | November 2, 2026 |
| Methylprednisolone acetate | 68083-616 | Injection, suspension | Generic drugs (ANDA) | November 2, 2026 |
| Epinephrine | 68083-701 | Injection | Generic drugs (ANDA) | October 26, 2026 |
| Buprenorphine hydrochloride | 68083-696 | Injection | Generic drugs (ANDA) | October 15, 2026 |
| Leucovorin Calcium | 68083-668 | Injection, powder, lyophilized, for solution | Generic drugs (ANDA) | October 14, 2026 |
| Levocarnitine | 68083-681 | Injection, solution | Generic drugs (ANDA) | September 30, 2026 |
| Epinephrine | 68083-699 | Injection | Generic drugs (ANDA) | September 22, 2026 |
| Atropine | 68083-671 | Solution/ drops | Generic drugs (ANDA) | July 31, 2026 |
| Atropine | 68083-670 | Solution/ drops | Generic drugs (ANDA) | July 31, 2026 |
| Atropine | 68083-669 | Solution/ drops | Generic drugs (ANDA) | July 31, 2026 |
| Sugammadex | 68083-442 | Injection, solution | Generic drugs (ANDA) | July 28, 2026 |
| Sugammadex | 68083-441 | Injection, solution | Generic drugs (ANDA) | July 28, 2026 |
| Brimonidine Tartrate and Timolol maleate Ophthalmic Solution | 68083-664 | Solution/ drops | Generic drugs (ANDA) | June 11, 2026 |
| Brimonidine Tartrate and Timolol maleate Ophthalmic Solution | 68083-625 | Solution/ drops | Generic drugs (ANDA) | June 11, 2026 |
| Brimonidine Tartrate and Timolol maleate Ophthalmic Solution | 68083-624 | Solution/ drops | Generic drugs (ANDA) | June 11, 2026 |
| Brimonidine Tartrate | 68083-626 | Solution/ drops | Generic drugs (ANDA) | March 11, 2026 |
| Zoledronic acid | 68083-672 | Injection, solution | Generic drugs (ANDA) | February 5, 2026 |
| Bortezomib | 68083-651 | Injection, powder, lyophilized, for solution | Generic drugs (ANDA) | January 6, 2026 |
| Bortezomib | 68083-650 | Injection, powder, lyophilized, for solution | Generic drugs (ANDA) | January 6, 2026 |
| Olopatadine Hydrochloride Ophthalmic Solution | 68083-398 | Solution | Generic drugs (ANDA) | January 6, 2026 |
| Olopatadine hydrochloride ophthalmic | 68083-398 | Solution | Export only | January 6, 2026 |
| Epoprostenol | 68083-707 | Injection, powder, lyophilized, for solution | Generic drugs (ANDA) | December 29, 2025 |
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.