Lignospan Forte

Product NDC
51004-1096
11-digit product format
510041096
Labeler code
51004
Product ID
51004-1096_0dc2796a-c3b3-48f3-b5e3-277d7646ca54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride and Epinephrine Bitartrate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novocol Pharmaceutical of Canada, Inc.
Application
ANDA088389
Marketing category
ANDA
Marketing start
2011-10-15
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
Active strength
20 mg/mL; mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51004-1096DDiscontinued by firm2026-08-03
excluded packagepackage51004-109651004-1096-7DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51004-1096-7DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51004-1096-7DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51004-1096-7DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51004-1096-7DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51004-1096-7DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51004-1096-7DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51004-1096-7DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51004-1096-7DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51004-1096-7DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51004-1096-7DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51004-1096-7DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51004-1096-7DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51004-1096-7IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51004-1096-7IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51004-1096-7EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088389-001LIGNOSPAN FORTEEPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-223f01610625f2…
2019-09-15 20:21 UTC2019-09A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088389-001LIGNOSPAN FORTEEQ 0.02MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Epinephrine BitartrateACTIVE INGREDIENT30Q7KI53AKLIGNOSPAN FORTE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]3
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPLIGNOSPAN FORTE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]3
EpinephrineACTIVE MOIETYYKH834O4BHLIGNOSPAN FORTE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]3
LIDOCAINEACTIVE MOIETY98PI200987LIGNOSPAN FORTE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]3
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KLIGNOSPAN FORTE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]3
Potassium MetabisulfiteINACTIVE INGREDIENT65OE787Q7WLIGNOSPAN FORTE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XLIGNOSPAN FORTE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ILIGNOSPAN FORTE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RLIGNOSPAN FORTE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]3

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.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dental9419ac39-9b26-4cca-a2d6-167205fede242026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088389
application number: ANDA088389
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLC27e8fdfb-e923-4f99-aff7-8b9e502281512026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088389
application number: ANDA088389
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dentalf074c0dc-7c3f-46fd-a480-b8337a19fe5c2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088389
application number: ANDA088389
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHenry Schein Inc.1ca96c77-d983-496b-84a6-54709e80f5322026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088389
application number: ANDA088389
Lignospan ForteLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.f8ca7d03-01c8-450f-9279-59789c3497ea2025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088389
application number: ANDA088389
XylocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDentsply Pharmaceutical14b55cf9-f7cd-4bb4-a7c5-aba61abadef12024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088389
application number: ANDA088389
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.df130310-41db-45df-a214-9da01cf0bf412024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088389
application number: ANDA088389