Brimonidine tartrate and Timolol maleate
- Product NDC
- 71921-188
- 11-digit product format
- 719210188
- Labeler code
- 71921
- Product ID
- 71921-188_0b25c3d0-6cf7-cce0-e063-6294a90a8ea9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brimonidine tartrate and Timolol maleate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Florida Pharmaceutical Products, LLC
- Application
- ANDA201949
- Marketing category
- ANDA
- Marketing start
- 2023-11-23
- Substance
- BRIMONIDINE TARTRATE; TIMOLOL MALEATE
- Active strength
- 2; 5 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRIMONIDINE TARTRATE | 2 mg/mL |
| TIMOLOL MALEATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4S9CL2DY2H, P8Y54F701R |
| Rxcui | 861635 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71921-188-05 | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 71921-188-05 | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 3 |
| 71921-188-10 | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 3 |
| 71921-188-10 | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 71921-188-15 | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | 15 mL in 1 BOTTLE, DROPPER | SOLUTION | 15 | | 3 |
| 71921-188-15 | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71921-188 | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE) SOLUTION [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] | 1 | Current NDC, 6 package rows | 20231129_7011a203-46cf-434d-ba11-253f107ff80f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71921-188-05 | 71921018805 | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER | 2023-11-23 | No | No | Historical |
| 71921-188-10 | 71921018810 | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER | 2023-11-23 | No | No | Historical |
| 71921-188-15 | 71921018815 | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER | 2023-11-23 | No | No | Historical |