Lidocaine Topical Ointment
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Avkare, Inc. (2015-09-25)
- Oldest Current Product
- 1972-06-30
- License(s)
- ANDA
- RxNORM
- TOPICAL OINTMENT\LIDOCAINE
- FDAOB
- TOPICAL\OINTMENT\LIDOCAINE
- SPL Active
- TOPICAL\OINTMENT\LIDOCAINE
- SPL Moiety
- TOPICAL\OINTMENT\LIDOCAINE
product(s) by strength(s)
lidocaine 0.05 mg/mg topical ointment
original product(s)(s)
| # | id | labeler | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|
| 1 | 422910378 | Avkare, Inc. | LIDOCAINE | TOPICAL | OINTMENT | 42abc81b-668f-7ec4-f37f-bdc5ac43465d |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001680204 | ANDA | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. | 1972-06-30 | LIDOCAINE | TOPICAL | OINTMENT | ANDA080198 | 88ca9cba-0c4a-482f-b502-ceefdb1bfbcd |
| 2 | 003620221 | ANDA | Septodont Inc. | 2015-05-20 | LIDOCAINE | TOPICAL | OINTMENT | ANDA040911 | 82a4c16f-d47e-479f-8f85-7d1be6fc2318 |
| 3 | 458610061 | ANDA | Pharmaceutica North America, Inc | 2015-08-13 | LIDOCAINE | TOPICAL | OINTMENT | ANDA086724 | 22693fd1-f831-49af-a389-26504e5db2eb |
| 4 | 503830933 | ANDA | Hi-Tech Pharmacal Co., Inc. | 2012-03-12 | LIDOCAINE | TOPICAL | OINTMENT | ANDA040911 | f130a654-ee3b-4daa-8dc6-8f514edf75a1 |
| 5 | 516723008 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 1981-08-17 | LIDOCAINE | TOPICAL | OINTMENT | ANDA086724 | 5eb2c62f-5352-41d7-bd66-c65b1988a9ab |
| 6 | 516723020 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 2013-03-25 | LIDOCAINE | TOPICAL | OINTMENT | ANDA086724 | ae758020-a508-4a2e-8164-e6c324e826a3 |
| 7 | 575390221 | ANDA | Novocol Inc. | 2011-10-01 | LIDOCAINE | TOPICAL | OINTMENT | ANDA040911 | c66b3509-c670-4124-86ac-da313958aabd |
| 8 | 651620918 | ANDA | Amneal Pharmaceuticals | 2015-08-10 | LIDOCAINE | TOPICAL | OINTMENT | ANDA206297 | d1509740-f9f1-44e3-8fde-51d8683fcd87 |
| 9 | 693290400 | ANDA | Patchwerx Labs, Inc. | 2012-03-12 | ANDA040911 | 1f498517-a3e6-00d7-e054-00144ff88e88, 1f49b979-a41f-08fd-e054-00144ff88e88 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 216950826 | ANDA | Rebel Distributors Corp | 1972-06-30 | LIDOCAINE | TOPICAL | OINTMENT | 001680204 | ANDA080198 | a1e2c14f-0682-4b19-9159-de0aca1960c6 |
| 2 | 332610564 | ANDA | Aidarex Pharmaceuticals Llc | 1972-06-30 | LIDOCAINE | TOPICAL | OINTMENT | 001680204 | ANDA080198 | 670287ac-9d8d-4514-b433-4adcca2d915a |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA040911 | LIDOCAINE | NOVOCOL INC | 2011-05-23 | ANDA040911_001 | |
| 2 | ANDA080198 | LIDOCAINE | E FOUGERA DIV ALTANA INC | ANDA080198_001 | ||
| 3 | ANDA080210 | LIDOCAINE | True | BELMORA LLC | ANDA080210_001 | |
| 4 | ANDA084944 | ALPHACAINE | True | CARLISLE LABORATORIES INC | ANDA084944_001 | |
| 5 | ANDA084946 | ALPHACAINE | True | CARLISLE LABORATORIES INC | ANDA084946_001 | |
| 6 | ANDA084947 | ALPHACAINE | True | CARLISLE LABORATORIES INC | ANDA084947_001 | |
| 7 | ANDA086724 | LIDOCAINE | TARO PHARMACEUTICALS USA INC | ANDA086724_001 | ||
| 8 | ANDA206297 | LIDOCAINE | AMNEAL PHARMACEUTICALS | 2015-08-07 | ANDA206297_001 | |
| 9 | NDA008048 | XYLOCAINE | True | ASTRAZENECA LP | NDA008048_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040911_001 | RX | LIDOCAINE (5%) | TOPICAL | OINTMENT | False | AT | 2011-05-23 | LIDOCAINE |
| 2 | ANDA080198_001 | RX | LIDOCAINE (5%) | TOPICAL | OINTMENT | True | AT | LIDOCAINE | |
| 3 | ANDA080210_001 | discontinued | LIDOCAINE (5%) | TOPICAL | OINTMENT | False | LIDOCAINE | ||
| 4 | ANDA084944_001 | discontinued | LIDOCAINE (5%) | TOPICAL | OINTMENT | False | ALPHACAINE | ||
| 5 | ANDA084946_001 | discontinued | LIDOCAINE (5%) | TOPICAL | OINTMENT | False | ALPHACAINE | ||
| 6 | ANDA084947_001 | discontinued | LIDOCAINE (5%) | TOPICAL | OINTMENT | False | ALPHACAINE | ||
| 7 | ANDA086724_001 | RX | LIDOCAINE (5%) | TOPICAL | OINTMENT | False | AT | LIDOCAINE | |
| 8 | ANDA206297_001 | RX | LIDOCAINE (5%) | TOPICAL | OINTMENT | False | AT | 2015-08-07 | LIDOCAINE |
| 9 | NDA008048_001 | discontinued | LIDOCAINE (5%) | TOPICAL | OINTMENT | False | XYLOCAINE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1f498517-a3e6-00d7-e054-00144ff88e88 (view SPL) | LidoRxKit | prescription | Human Prescription | Patchwerx Labs, Inc. | 2015-09-07 | 1 | 693290400 | |
| 2 | 1f49b979-a41f-08fd-e054-00144ff88e88 (view SPL) | LidoRxKit | prescription | Human Prescription | Patchwerx Labs, Inc. | 2015-09-09 | 2 | 693290400 | |
| 3 | 22693fd1-f831-49af-a389-26504e5db2eb (view SPL) | Lidocaine Ointment USP, 5% | prescription | Human Prescription | Pharmaceutica North America, Inc | 2015-08-13 | 1 | 458610061 | |
| 4 | 42abc81b-668f-7ec4-f37f-bdc5ac43465d (view SPL) | LidocaineOintment USP, 5% | prescription | Human Prescription | Avkare, Inc. | 2015-09-25 | 2 | 422910378 | |
| 5 | 5eb2c62f-5352-41d7-bd66-c65b1988a9ab (view SPL) | LIDOCAINE OINTMENT USP, 5% (Spearmint Flavored) | prescription | Human Prescription | Taro Pharmaceuticals U.S.A., Inc. | MANUFACTURE | 2015-06-29 | 3 | 516723008 |
| 6 | 670287ac-9d8d-4514-b433-4adcca2d915a (view SPL) | LIDOCAINE OINTMENT USP, 5% | prescription | Human Prescription | Aidarex Pharmaceuticals Llc | 2014-01-09 | 1 | 332610564 | |
| 7 | 82a4c16f-d47e-479f-8f85-7d1be6fc2318 (view SPL) | LIDOCAINE OINTMENT USP, 5% | prescription | Human Prescription | Septodont Inc. | label, manufacture | 2015-05-05 | 1 | 003620221 |
| 8 | 88ca9cba-0c4a-482f-b502-ceefdb1bfbcd (view SPL) | LIDOCAINE OINTMENT USP, 5% | prescription | Human Prescription | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. | 2014-08-22 | 4 | 001680204 | |
| 9 | a1e2c14f-0682-4b19-9159-de0aca1960c6 (view SPL) | LIDOCAINE OINTMENT USP, 5% | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2010-10-01 | 1 | 216950826 |
| 10 | ae758020-a508-4a2e-8164-e6c324e826a3 (view SPL) | Lidocaine Ointment USP, 5% | prescription | Human Prescription | Taro Pharmaceuticals U.S.A., Inc. | MANUFACTURE | 2015-04-20 | 2 | 516723020 |
| 11 | c66b3509-c670-4124-86ac-da313958aabd (view SPL) | LIDOCAINE OINTMENT USP, 5% | prescription | Human Prescription | Novocol Inc. | LABEL, MANUFACTURE | 2011-12-09 | 1 | 575390221 |
| 12 | d1509740-f9f1-44e3-8fde-51d8683fcd87 (view SPL) | Lidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only | prescription | Human Prescription | Amneal Pharmaceuticals | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-08-13 | 5 | 651620918 |
| 13 | f130a654-ee3b-4daa-8dc6-8f514edf75a1 (view SPL) | LIDOCAINE OINTMENT USP, 5% | prescription | Human Prescription | Hi-Tech Pharmacal Co., Inc. | LABEL, MANUFACTURE | 2012-03-23 | 2 | 503830933 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII