timolol maleate
- Product NDC
- 81469-209
- 11-digit product format
- 814690209
- Labeler code
- 81469
- Product ID
- 81469-209_b666fc6c-b409-45a6-a890-fa5b41585390
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- timolol maleate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- First Nation Group, LLC
- Application
- ANDA078771
- Marketing category
- ANDA
- Marketing start
- 2024-05-10
- Substance
- TIMOLOL MALEATE
- Active strength
- 2.5 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], 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
- timolol maleate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIMOLOL MALEATE | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P8Y54F701R |
| Rxcui | 1923428, 1992303 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81469-209-05 | timolol maleate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 1 |
| 81469-209-05 | timolol maleate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 81469-209-10 | timolol maleate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 1 |
| 81469-209-10 | timolol maleate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81469-209 | TIMOLOL MALEATE SOLUTION/ DROPS [FIRST NATION GROUP, LLC] | 1 | Current NDC, 4 package rows | 20240510_140e1bfc-b75e-40d1-856c-242be4d9c8cc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81469-209-05 | 81469020905 | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 5 mL in 1 BOTTLE, DROPPER | 2024-05-10 | No | No | Historical |
| 81469-209-10 | 81469020910 | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 10 mL in 1 BOTTLE, DROPPER | 2024-05-10 | No | No | Historical |