Timoptic in Ocudose
- Product NDC
- 69918-601
- 11-digit product format
- 699180601
- Labeler code
- 69918
- Product ID
- 69918-601_568ed4c4-e34b-4dda-a1ff-8d9fcf9ff502
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Nordic Pharma, Inc.
- Application
- ANDA212592
- Marketing category
- ANDA
- Marketing start
- 2022-02-26
- Substance
- TIMOLOL MALEATE
- Active strength
- 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
- Timoptic in Ocudose
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIMOLOL MALEATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P8Y54F701R |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69918-601-60 | Timoptic in Ocudose | 60 in 1 CARTON | SOLUTION | 60 | | 5 |
| 69918-601-60 | Timoptic in Ocudose | 10 in 1 POUCH | SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69918-601 | TIMOPTIC IN OCUDOSE (TIMOLOL MALEATE) SOLUTION [NORDIC PHARMA, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250323_16323b0e-78ae-40e5-be93-04f698dd672b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69918-601-60 | 69918060160 | 60 POUCH in 1 CARTON (69918-601-60) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER | 60 pouch | 2022-02-26 | 0000-00-00 | No | No | Current |