Varenicline
- Product NDC
- 10135-808
- 11-digit product format
- 101350808
- Labeler code
- 10135
- Product ID
- 10135-808_4db2ad18-c1a0-81b8-e063-6394a90ac1d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Varenicline tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA217283
- Marketing category
- ANDA
- Marketing start
- 2025-01-01
- Substance
- VARENICLINE TARTRATE
- Active strength
- .5 mg/1
- Pharmacologic classes
- Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Varenicline
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VARENICLINE TARTRATE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82269ASB48 |
| Rxcui | 636671, 636676 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-808-56 | Varenicline | 56 in 1 BOTTLE | TABLET, FILM COATED | 56 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-808 | VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED [MARLEX PHARMACEUTICALS, INC.] | 2 | Current NDC, 1 package rows | 20250406_29b6b4ca-aeef-1295-e063-6394a90a21b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-808-56 | 10135080856 | 56 TABLET, FILM COATED in 1 BOTTLE (10135-808-56) | 2025-01-01 | No | No | Current |