ZOLYMBUS
- Product NDC
- 82584-010
- 11-digit product format
- 825840010
- Labeler code
- 82584
- Product ID
- 82584-010_4badbaf4-122e-3878-e063-6294a90ab4ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bimatoprost
- Dosage form
- GEL
- Route
- OPHTHALMIC
- Labeler
- Thea Pharma Inc.
- Application
- NDA217307
- Marketing category
- NDA
- Marketing start
- 2026-02-26
- Substance
- BIMATOPROST
- Active strength
- .1 mg/g
- Pharmacologic classes
- Prostaglandin Analog [EPC], Prostaglandins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZOLYMBUS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BIMATOPROST | .1 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | QXS94885MZ |
| Rxcui | 2725168, 2725620 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f71952f0-5c3a-ff37-f1fb-fed3868f6302 | Product name | 8 | 20260105 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 546f403c-5466-48b9-a79e-80b68d2b77d8 | Product name | 1 | 20200706 |
| 3471d048-4165-432e-a2dc-905eb43247db | Product name | 4 | 20200611 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82584-010-10 | ZOLYMBUS | 1 in 1 CARTON | GEL | 1 | 5 | |
| 82584-010-10 | ZOLYMBUS | 10 in 1 POUCH | GEL | 10 | 5 | |
| 82584-010-30 | ZOLYMBUS | 3 in 1 CARTON | GEL | 3 | 5 | |
| 82584-010-35 | ZOLYMBUS | 10 in 1 POUCH | GEL | 10 | 5 | |
| 82584-010-35 | ZOLYMBUS | 3 in 1 CARTON | GEL | 3 | 5 | |
| 82584-010-81 | ZOLYMBUS | 0.3 g in 1 VIAL, SINGLE-DOSE | GEL | 0.3 | 5 | |
| 82584-010-81 | ZOLYMBUS | 10 in 1 POUCH | GEL | 10 | 5 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2725168 | bimatoprost 0.01 % Ophthalmic Gel | PSN | f4504a0c-7998-4084-9e05-f999f1d051ed | 5 |
| 2725620 | ZOLYMBUS 0.01 % Ophthalmic Gel | PSN | f4504a0c-7998-4084-9e05-f999f1d051ed | 5 |
| 2725620 | bimatoprost 0.0001 MG/MG Ophthalmic Gel [Zolymbus] | SBD | f4504a0c-7998-4084-9e05-f999f1d051ed | 5 |
| 2725168 | bimatoprost 0.0001 MG/MG Ophthalmic Gel | SCD | f4504a0c-7998-4084-9e05-f999f1d051ed | 5 |
| 2725168 | bimatoprost 0.01 % Ophthalmic Gel | SY | f4504a0c-7998-4084-9e05-f999f1d051ed | 5 |
| 2725620 | Zolymbus 0.0001 MG/MG Ophthalmic Gel | SY | f4504a0c-7998-4084-9e05-f999f1d051ed | 5 |
| 2725620 | Zolymbus 0.01 % Ophthalmic Gel | SY | f4504a0c-7998-4084-9e05-f999f1d051ed | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82584-010-10 | 82584001010 | 1 POUCH in 1 CARTON (82584-010-10) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .3 g in 1 VIAL, SINGLE-DOSE | 1 pouch | 2026-02-26 | Yes | No | Historical |
| 82584-010-30 | 82584001030 | 3 POUCH in 1 CARTON (82584-010-30) / 10 VIAL, SINGLE-DOSE in 1 POUCH (82584-010-81) / .3 g in 1 VIAL, SINGLE-DOSE | 3 pouch | 2026-02-26 | No | No | Historical |
| 82584-010-35 | 82584001035 | 3 POUCH in 1 CARTON (82584-010-35) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .3 g in 1 VIAL, SINGLE-DOSE | 3 pouch | 2026-02-26 | Yes | No | Historical |
| 82584-010-81 | 82584001081 | 0.3 g in 1 VIAL, SINGLE-DOSE | 0.3 g | Historical |