Lamotrigine
- Product NDC
- 64679-275
- 11-digit product format
- 646790275
- Labeler code
- 64679
- Product ID
- 64679-275_b7778fde-0a8a-0857-e053-2995a90a2240
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Wockhardt USA LLC.
- Application
- ANDA202498
- Marketing category
- ANDA
- Marketing start
- 2012-11-29
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64679-275 | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 5 | Legacy NDC | 20201228_0e9b23d9-0813-4fb5-848d-776453f361f7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64679-275-01 | 64679027501 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64679-275-01) | | 2012-11-29 | 0000-00-00 | No | No | Current |
| 64679-275-02 | 64679027502 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (64679-275-02) | | 2012-11-29 | 0000-00-00 | No | No | Current |
| 64679-275-04 | 64679027504 | 10 BLISTER PACK in 1 CARTON (64679-275-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (64679-275-03) | 10 blister pack | 2012-11-29 | 0000-00-00 | No | No | Current |