Nicotine Polacrilex
- Product NDC
- 43598-489
- Requested package NDC
- 43598-489-22
- 11-digit product format
- 435980489
- Labeler code
- 43598
- Product ID
- 43598-489_ea14d88d-2ad8-b2e9-bf8f-8a299e66d618
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA213233
- Marketing category
- ANDA
- Marketing start
- 2020-10-01
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213233-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2020-08-04 | ||
| A213233-002 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2020-08-04 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A213233-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2020-08-04 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A213233-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2020-08-04 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Habitrol Lozenge Cherry | NICOTINE POLACRILEX | Dr. Reddy's Laboratories Inc. | 5a464242-7d63-141e-808e-c41676cf4b78 | 2026-07-09 | Warnings | 213233 ANDA213233 |
| Nicotine Polacrilex | NICOTINE POLACRILEX | Dr. Reddy's Laboratories Inc. | 6b0342dd-120f-a16e-098a-dc45b14d3d3a | 2026-07-09 | Warnings | 213233 ANDA213233 43598-489-22 43598-489 43598048922 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Polacrilex
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NICOTINE | 4 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6M3C89ZY6R | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6b0342dd-120f-a16e-098a-dc45b14d3d3a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43598-489-22 | 43598048922 | 10 BOTTLE in 1 CARTON (43598-489-22) / 24 LOZENGE in 1 BOTTLE | 10 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |