Prescription drug · ANDA
Bimatoprost NDC 68083-439
Bimatoprost .3 mg/mL · Solution/ drops · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-439-01 | 6808304390168083043901 | 1 BOTTLE in 1 CARTON (68083-439-01) / 7.5 mL in 1 BOTTLEMarketed from Aug 12, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bimatoprost
- Generic name (nonproprietary)
- bimatoprost
- Active ingredients
- Bimatoprost — .3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210126
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins (Chemical structure)
- Identifiers
- Product ID 68083-439_512bd5c6-1e5d-4423-b06e-9fe80ff833c2SPL ID 512bd5c6-1e5d-4423-b06e-9fe80ff833c2SPL set ID 2a4b5b6b-fc47-40d2-8396-ff60511a4cd1RxCUI 308739UNII QXS94885MZ
- Pharmacologic class
- Prostaglandin Analog
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468083043901followed by a unit qualifier and the quantityPackage 68083-0439-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Bimatoprost ophthalmic solution, 0.03% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68083-439
- What is NDC 68083-439?
- 68083-439 is the product NDC for Bimatoprost, Bimatoprost .3 mg/mL solution/ drops, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bimatoprost.
- What is the active ingredient?
- Bimatoprost.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bimatoprost?
- 23 other product NDCs are listed under this name. See all Bimatoprost NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bimatoprost products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bimatoprost | Bimatoprost .1 mg/mL | Solution/ dropsOphthalmic | First Nation Group, LLC | 81469-291 | 81469-0291-0581469-0291-25 |
| Bimatoprost | Bimatoprost .1 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-626 | 70756-0626-30 |
| Bimatoprost | Bimatoprost .1 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-627 | 70756-0627-30 |
| Bimatoprost | Bimatoprost .1 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-628 | 70756-0628-30 |
| Bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | Fosun Pharma USA Inc. | 72266-241 | 72266-0241-01 |
| Bimatoprost | Bimatoprost .1 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-2149 | 60219-2149-0160219-2149-0260219-2149-04 |
| bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-511 | 46708-0511-0346708-0511-05 |
| Bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | Aurobindo Pharma Limited | 65862-802 | 65862-0802-0565862-0802-1065862-0802-44 |
| Bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | Micro Labs Limited | 42571-128 | 42571-0128-2142571-0128-2842571-0128-35 |
| Bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3612 | 68071-3612-05 |
Other NDCs under ANDA 210126
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3590 |
| Bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-296 |
| Bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-295 |
| Bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | Fosun Pharma USA Inc. | 72266-140 |
| Bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | Fosun Pharma USA Inc. | 72266-139 |
| Bimatoprost | Bimatoprost .3 mg/mL | Solution/ dropsOphthalmic | Fosun Pharma USA Inc. | 72266-241 |