Habitrol
- Product NDC
- 55741-448
- 11-digit product format
- 557410448
- Labeler code
- 55741
- Product ID
- 55741-448_7b8f92dc-a9f4-6c9c-d0ca-bd8f89cbd875
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Transdermal System Patch
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- NDA020076
- Marketing category
- NDA
- Marketing start
- 2018-07-13
- Substance
- NICOTINE
- Active strength
- 21 mg/24h
- 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 |
|---|---|---|---|---|---|---|---|
| N020076-004 | HABITROL | NICOTINE | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | |
| N020076-005 | HABITROL | NICOTINE | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | |
| N020076-006 | HABITROL | NICOTINE | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Habitrol
- Brand name suffix
- Step 1
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NICOTINE | 21 mg/24h |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6M3C89ZY6R | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55741-448-28 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f9cf-111a-e063-dadaa90a10e2 | Drug Facts |
| 55741-448-70 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f9cf-111a-e063-dadaa90a10e2 | Drug Facts |
| 55741-448-74 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f9cf-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55741-448-28 | Habitrol Step 1 | 28 in 1 CARTON | PATCH, EXTENDED RELEASE | 28 | 12 | |
| 55741-448-28 | Habitrol Step 1 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | 12 | |
| 55741-448-70 | Habitrol Step 1 | 7 in 1 CARTON | PATCH, EXTENDED RELEASE | 7 | 12 | |
| 55741-448-70 | Habitrol Step 1 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | 12 | |
| 55741-448-74 | Habitrol Step 1 | 14 in 1 CARTON | PATCH, EXTENDED RELEASE | 14 | 12 | |
| 55741-448-74 | Habitrol Step 1 | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55741-448-70 | EA - Each | 55741-448 | a712a4d5-d831-41d5-8e45-c3ba115b2930 | 1 | 2024-04-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55741-448 | HABITROL STEP 1 (NICOTINE TRANSDERMAL SYSTEM PATCH ) PATCH, EXTENDED RELEASE HABITROL STEP 2 (NICOTINE TRANSDERMAL SYSTEM PATCH ) PATCH, EXTENDED RELEASE HABITROL STEP 3 (NICOTINE TRANSDERMAL SYSTEM PATCH ) PATCH, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.] | 12 | Current NDC, Legacy NDC, 6 package rows | 20240726_051be7ae-6504-c2d8-7424-2e328e4fcfc2.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 207716 | Habitrol (Step 1) 21 MG/Day 24HR Transdermal System | PSN | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207712 | Habitrol (Step 2) 14 MG/Day 24HR Transdermal System | PSN | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207734 | Habitrol (Step 3) 7 MG/Day 24HR Transdermal System | PSN | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198029 | nicotine 14 MG/Day 24HR Transdermal System | PSN | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | PSN | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | PSN | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207734 | 24 HR nicotine 0.292 MG/HR Transdermal System [Habitrol] | SBD | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207712 | 24 HR nicotine 0.583 MG/HR Transdermal System [Habitrol] | SBD | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207716 | 24 HR nicotine 0.875 MG/HR Transdermal System [Habitrol] | SBD | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198031 | 24 HR nicotine 0.292 MG/HR Transdermal System | SCD | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198029 | 24 HR nicotine 0.583 MG/HR Transdermal System | SCD | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198030 | 24 HR nicotine 0.875 MG/HR Transdermal System | SCD | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207734 | 24 HR Habitrol 0.292 MG/HR Transdermal System | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207712 | 24 HR Habitrol 0.583 MG/HR Transdermal System | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207716 | 24 HR Habitrol 0.875 MG/HR Transdermal System | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207716 | Habitrol (Step 1) 21 MG/Day 24HR Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207712 | Habitrol (Step 2) 14 MG/Day 24HR Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207734 | Habitrol (Step 3) 7 MG/Day 24HR Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207734 | Habitrol (Step 3) 7 MG/Day 24HR Transdermal System | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207734 | Habitrol 0.292 MG/HR 24HR Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207712 | Habitrol 0.583 MG/HR 24 HR Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 207716 | Habitrol 0.875 MG/HR 24HR Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198031 | nicotine 0.292 MG/HR 24HR Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198029 | nicotine 0.583 MG/HR 24HR Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198030 | nicotine 0.875 MG/HR 24HR Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198029 | nicotine 14 MG per 24HR 1 Day Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198029 | nicotine 14 MG/Day 24HR Transdermal System | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198030 | nicotine 21 MG per 24HR 1 Day Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198031 | nicotine 7 MG per 24HR 1 Day Transdermal Patch | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | SY | 051be7ae-6504-c2d8-7424-2e328e4fcfc2 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55741-448-28 | 55741044828 | 28 PATCH in 1 CARTON (55741-448-28) / 24 h in 1 PATCH | 28 patch | 2019-07-01 | 0000-00-00 | No | No | Current |
| 55741-448-70 | 55741044870 | 7 PATCH in 1 CARTON (55741-448-70) / 24 h in 1 PATCH | 7 patch | 2019-06-15 | 0000-00-00 | No | No | Current |
| 55741-448-74 | 55741044874 | 14 PATCH in 1 CARTON (55741-448-74) / 24 h in 1 PATCH | 14 patch | 2019-06-15 | 0000-00-00 | No | No | Current |