FDA.reportPublic FDA data

Plenamine

Product NDC
0264-4500
11-digit product format
002644500
Labeler code
0264
Product ID
0264-4500_905f7c55-bf0d-4150-90ef-e8f1a5455bc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
ANDA091112
Marketing category
ANDA
Marketing start
2018-09-28
Substance
ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
Active strength
2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960 g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes
Amino Acid [EPC], Amino Acids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Plenamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALANINE2.17 g/100mL
ARGININE1.47 g/100mL
ASPARTIC ACID434 mg/100mL
GLUTAMIC ACID749 mg/100mL
GLYCINE1.04 g/100mL
HISTIDINE894 mg/100mL
ISOLEUCINE749 mg/100mL
LEUCINE1.04 g/100mL
LYSINE ACETATE1.18 g/100mL
METHIONINE749 mg/100mL
PHENYLALANINE1.04 g/100mL
PROLINE894 mg/100mL
SERINE592 mg/100mL
THREONINE749 mg/100mL
TRYPTOPHAN250 mg/100mL
TYROSINE39 mg/100mL
VALINE960 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOF5P57N2ZX, 94ZLA3W45F, 30KYC7MIAI, 3KX376GY7L, TE7660XO1C, 4QD397987E, 04Y7590D77, GMW67QNF9C, TTL6G7LIWZ, AE28F7PNPL, 47E5O17Y3R, 9DLQ4CIU6V, 452VLY9402, 2ZD004190S, 8DUH1N11BX, 42HK56048U, HG18B9YRS7
Rxcui800584, 1601982

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-4500-00Plenamine8 in 1 CASESOLUTION89
0264-4500-00Plenamine1000 mL in 1 CONTAINERSOLUTION10009
0264-4500-05Plenamine4 in 1 CASESOLUTION49
0264-4500-05Plenamine2000 mL in 1 CONTAINERSOLUTION20009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-4500-00ML - Milliliter0264-450098d7a258-2117-48d5-8955-a99c44f47fe012019-05-02
0264-4500-05ML - Milliliter0264-4500947b517e-15f0-4051-9d0e-3608f8c0aadb12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-4500PLENAMINE (LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINE) SOLUTION [B. BRAUN MEDICAL INC.]8Current NDC, Legacy NDC, 4 package rows20230427_a3244d1a-45b0-4e4c-bd96-f0632d761a1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601982Plenamine 15 % Injectable SolutionPSNa3244d1a-45b0-4e4c-bd96-f0632d761a1f9
1601982alanine 21.7 MG/ML / arginine 14.7 MG/ML / aspartate 4.34 MG/ML / glutamate 7.49 MG/ML / glycine 10.4 MG/ML / histidine 8.94 MG/ML / isoleucine 7.49 MG/ML / leucine 10.4 MG/ML / lysine 11.8 MG/ML / methionine 7.49 MG/ML / phenylalanine 10.4 MG/ML / proline 8.94 MG/ML / serine 5.92 MG/ML / threonine 7.49 MG/ML / tryptophan 2.5 MG/ML / tyrosine 0.39 MG/ML / valine 9.6 MG/ML Injectable Solution [Plenamine]SBDa3244d1a-45b0-4e4c-bd96-f0632d761a1f9
800584alanine 21.7 MG/ML / arginine 14.7 MG/ML / aspartate 4.34 MG/ML / glutamate 7.49 MG/ML / glycine 10.4 MG/ML / histidine 8.94 MG/ML / isoleucine 7.49 MG/ML / leucine 10.4 MG/ML / lysine 11.8 MG/ML / methionine 7.49 MG/ML / phenylalanine 10.4 MG/ML / proline 8.94 MG/ML / serine 5.92 MG/ML / threonine 7.49 MG/ML / tryptophan 2.5 MG/ML / tyrosine 0.39 MG/ML / valine 9.6 MG/ML Injectable SolutionSCDa3244d1a-45b0-4e4c-bd96-f0632d761a1f9
1601982Plenamine 15 % Amino Acids InjectionSYa3244d1a-45b0-4e4c-bd96-f0632d761a1f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-4500-00002644500008 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINER8 container2018-09-280000-00-00NoNoCurrent
0264-4500-05002644500054 CONTAINER in 1 CASE (0264-4500-05) / 2000 mL in 1 CONTAINER4 container2019-10-290000-00-00NoNoCurrent