Prescription drug · ANDA
lamotrigine (Lamotrigine extended-release) NDC 69117-0049
Lamotrigine 300 mg/1 · Tablet, Film coated, Extended release · Oral · Yiling Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69117-0049-1 | 6911700490169117004901 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0049-1)Marketed from Dec 9, 2021 | |
| 69117-0049-2 | 6911700490269117004902 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0049-2)Marketed from Dec 9, 2021 | |
| 69117-0049-3 | 6911700490369117004903 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0049-3)Marketed from Dec 9, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- lamotrigine
- Generic name (nonproprietary)
- lamotrigine extended-release
- Active ingredients
- Lamotrigine — 300 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Yiling Pharmaceutical, Inc.NDC labeler code 69117
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213949
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 69117-0049_47239426-3d75-73d8-e063-6294a90a608dSPL ID 47239426-3d75-73d8-e063-6294a90a608dSPL set ID f7de11a5-5357-4753-b1ac-b15123b50028RxCUI 850087, 850091, 900156, 900164, 1098608, 1146690UNII U3H27498KSUPC 0369117004920, 0369117004739, 0369117004517, 0369117004913, 0369117004425, 0369117004722, 0369117004838, 0369117004418, 0369117004616, 0369117004623, 0369117004715, 0369117004432, 0369117004524, 0369117004814, 0369117004821, 0369117004630, 0369117004937, 0369117004531
- Pharmacologic class
- Anti-epileptic Agent; Mood Stabilizer
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469117004901followed by a unit qualifier and the quantityPackage 69117-0049-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Lamotrigine Extended-Release Tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1 ) conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. ( 1.2 ) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. ( 1.3 ) 1.1 Adjunctive Therapy Lamotrigine Extended-Release Tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without s…
Excerpt only. Read the full label for complete information.
About NDC 69117-0049
- What is NDC 69117-0049?
- 69117-0049 is the product NDC for lamotrigine (lamotrigine extended-release), Lamotrigine 300 mg/1 tablet, film coated, extended release, listed with the FDA by Yiling Pharmaceutical, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- lamotrigine (Lamotrigine extended-release).
- What is the active ingredient?
- Lamotrigine.
- Who is the labeler?
- Yiling Pharmaceutical, Inc., NDC labeler code 69117. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for lamotrigine?
- 262 other product NDCs are listed under this name. See all lamotrigine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other lamotrigine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4702 | 70518-4702-00 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Coupler LLC | 67046-0358 | 67046-0358-03 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Coupler LLC | 67046-0749 | 67046-0749-03 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Coupler LLC | 67046-0359 | 67046-0359-03 |
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4638 | 70518-4638-00 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-770 | 62332-0770-1562332-0770-30 |
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-771 | 62332-0771-1562332-0771-30 |
| Lamotrigine | Lamotrigine 100 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-772 | 62332-0772-1062332-0772-30 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-773 | 62332-0773-1062332-0773-30 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-770 | 46708-0770-1546708-0770-30 |
Other NDCs under ANDA 213949
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4638 |
| Lamotrigine ER | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_rx | 72189-560 |
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4442 |
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 82804-022 |
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0047 |
| lamotriginelamotrigine extended-release | Lamotrigine 25 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0044 |
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0045 |
| lamotriginelamotrigine extended-release | Lamotrigine 100 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0046 |
| lamotriginelamotrigine extended-release | Lamotrigine 250 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0048 |
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-241 |
| lamotriginelamotrigine extended-release | Lamotrigine 25 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-240 |
| lamotriginelamotrigine extended-release | Lamotrigine 300 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-245 |
| lamotriginelamotrigine extended-release | Lamotrigine 100 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-242 |
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-243 |
| lamotriginelamotrigine extended-release | Lamotrigine 250 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-244 |