Succinylcholine Chloride Injection USP, 20 mg/mL

Manufacturer
Renaissance Lakewood LLC
Effective date
2018-06-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:41:42

Label at a glance#

ProductSuccinylcholine Chloride
Active ingredientSUCCINYLCHOLINE CHLORIDE
Label structure2 sections

Boxed warning

WARNING RISK OF CARDIAC ARREST FROM HYPERKALEMIC RHABDOMYOLYSIS There have been rare reports of acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest and death after the administration of succinylcholine to apparently healthy pediatric patients who were subsequently found to have undiagnosed skeletal muscle myopathy, most frequently Duchenne’s muscular dystrophy. This syndrome...

Label contents#

Full prescribing information#

BOXED WARNING SECTION

WARNING

RISK OF CARDIAC ARREST FROM HYPERKALEMIC RHABDOMYOLYSIS

There have been rare reports of acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest and death after the administration of succinylcholine to apparently healthy pediatric patients who were subsequently found to have undiagnosed skeletal muscle myopathy, most frequently Duchenne’s muscular dystrophy.

This syndrome often presents as peaked T-waves and sudden cardiac arrest within minutes after the administration of the drug in healthy appearing pediatric patients (usually, but not exclusively, males, and most frequently 8 years of age or younger). There have also been reports in adolescents.

Therefore, when a healthy appearing infant or child develops cardiac arrest soon after administration of succinylcholine, not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose, immediate treatment for hyperkalemia should be instituted. This should include administration of intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation. Due to the abrupt onset of this syndrome, routine resuscitative measures are likely to be unsuccessful. However, extraordinary and prolonged resuscitative efforts have resulted in successful resuscitation in some reported cases. In addition, in the presence of signs of malignant hyperthermia, appropriate treatment should be instituted concurrently.

Since there may be no signs or symptoms to alert the practitioner to which patients are at risk, it is recommended that the use of succinylcholine in pediatric patients should be reserved for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION).

Primary package for Succinylcholine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49396-015249396-0152-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCCINYLCHOLINE CHLORIDEI9L0DDD30IACTIB
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210231-001SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A210231-001AP

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-0484e616aacf4f…
2026-08-18 06:07:402026-07A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-043f01610625f2…
2019-09-15 20:21 UTC2019-09A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210231-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAP2018-06-04f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210231-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A210231-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210231-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210231-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210231-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210231-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210231-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210231-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210231-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210231-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210231-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210231-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210231-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210231-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210231-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210231-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210231-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210231-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210231-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210231-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210231-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210231-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210231-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A210231-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210231-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210231-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210231-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A210231-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210231-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210231-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210231-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210231-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210231-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210231-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210231-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210231-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210231-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210231-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210231-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210231-001AP1f41ea6bd6efb…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6e8a325b-92ce-b657-e053-2991aa0a181b6e8a325b-92cd-b657-e053-2991aa0a181b2018-06-13Boxed warningExact identifier
spl id: 6e8a325b-92ce-b657-e053-2991aa0a181b
spl set id: 6e8a325b-92cd-b657-e053-2991aa0a181b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.