Nicotine Polacrilex
- Product NDC
- 43598-486
- 11-digit product format
- 435980486
- Labeler code
- 43598
- Product ID
- 43598-486_33e2c1b3-2ea4-98f4-47c2-320c8ddd608e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA212796
- Marketing category
- ANDA
- Marketing start
- 2020-06-09
- Substance
- NICOTINE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Polacrilex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 359817, 359818 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-486 | NICOTINE POLACRILEX LOZENGE [DR. REDDY'S LABORATORIES INC.] | 7 | Current NDC, Legacy NDC | 20240706_b0fdb36d-4cf5-8a91-3da1-90e3587450f9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-486-10 | 43598048610 | 4 BOTTLE in 1 CARTON (43598-486-10) / 27 LOZENGE in 1 BOTTLE | 4 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-12 | 43598048612 | 5 BOTTLE in 1 CARTON (43598-486-12) / 24 LOZENGE in 1 BOTTLE | 5 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-13 | 43598048613 | 5 BOTTLE in 1 CARTON (43598-486-13) / 27 LOZENGE in 1 BOTTLE | 5 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-14 | 43598048614 | 6 BOTTLE in 1 CARTON (43598-486-14) / 24 LOZENGE in 1 BOTTLE | 6 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-16 | 43598048616 | 6 BOTTLE in 1 CARTON (43598-486-16) / 27 LOZENGE in 1 BOTTLE | 6 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-17 | 43598048617 | 7 BOTTLE in 1 CARTON (43598-486-17) / 24 LOZENGE in 1 BOTTLE | 7 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-18 | 43598048618 | 7 BOTTLE in 1 CARTON (43598-486-18) / 27 LOZENGE in 1 BOTTLE | 7 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-19 | 43598048619 | 8 BOTTLE in 1 CARTON (43598-486-19) / 24 LOZENGE in 1 BOTTLE | 8 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-22 | 43598048622 | 10 BOTTLE in 1 CARTON (43598-486-22) / 24 LOZENGE in 1 BOTTLE | 10 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-23 | 43598048623 | 8 BOTTLE in 1 CARTON (43598-486-23) / 27 LOZENGE in 1 BOTTLE | 8 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-24 | 43598048624 | 1 BOTTLE in 1 CARTON (43598-486-24) / 24 LOZENGE in 1 BOTTLE | 1 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-27 | 43598048627 | 1 BOTTLE in 1 CARTON (43598-486-27) / 27 LOZENGE in 1 BOTTLE | 1 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-29 | 43598048629 | 10 BOTTLE in 1 CARTON (43598-486-29) / 27 LOZENGE in 1 BOTTLE | 10 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-48 | 43598048648 | 2 BOTTLE in 1 CARTON (43598-486-48) / 24 LOZENGE in 1 BOTTLE | 2 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-54 | 43598048654 | 2 BOTTLE in 1 CARTON (43598-486-54) / 27 LOZENGE in 1 BOTTLE | 2 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-72 | 43598048672 | 3 BOTTLE in 1 CARTON (43598-486-72) / 24 LOZENGE in 1 BOTTLE | 3 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-73 | 43598048673 | 7 BOTTLE in 1 CARTON (43598-486-73) / 24 LOZENGE in 1 BOTTLE | 7 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-74 | 43598048674 | 7 BOTTLE in 1 CARTON (43598-486-74) / 27 LOZENGE in 1 BOTTLE | 7 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-81 | 43598048681 | 3 BOTTLE in 1 CARTON (43598-486-81) / 27 LOZENGE in 1 BOTTLE | 3 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-96 | 43598048696 | 4 BOTTLE in 1 CARTON (43598-486-96) / 24 LOZENGE in 1 BOTTLE | 4 bottle | 2020-06-09 | 0000-00-00 | No | No | Current |
| 43598-486-99 | 43598048699 | 8333 LOZENGE in 1 POUCH (43598-486-99) | 8333 lozenge | 08-JAN-20 | | | | Current |