Home NDC 0264-4500 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091112-001 AMINO ACIDS AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 A091112-002 AMINO ACIDS AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13
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 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091112-001 AMINO ACIDS 15%(150GM/1000ML) INJECTABLE / INJECTION 2012-04-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091112-002 AMINO ACIDS 15%(300GM/2000ML) INJECTABLE / INJECTION 2012-04-13 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Plenamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LYSINE ACETATE 2.17 g/100mL LEUCINE 1.47 g/100mL PHENYLALANINE 434 mg/100mL VALINE 749 mg/100mL ISOLEUCINE 1.04 g/100mL METHIONINE 894 mg/100mL THREONINE 749 mg/100mL TRYPTOPHAN 1.04 g/100mL ALANINE 1.18 g/100mL ARGININE 749 mg/100mL GLYCINE 1.04 g/100mL HISTIDINE 894 mg/100mL PROLINE 592 mg/100mL GLUTAMIC ACID 749 mg/100mL SERINE 250 mg/100mL ASPARTIC ACID 39 mg/100mL TYROSINE 960 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 17 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 800584 Internal RxNorm lookup 1601982 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0264-4500-00 Plenamine 8 in 1 CASE SOLUTION 8 9 0264-4500-00 Plenamine 1000 mL in 1 CONTAINER SOLUTION 1000 9 0264-4500-05 Plenamine 4 in 1 CASE SOLUTION 4 9 0264-4500-05 Plenamine 2000 mL in 1 CONTAINER SOLUTION 2000 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-4500 PLENAMINE (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.] 8 Current NDC, Legacy NDC, 4 package rows 20230427_a3244d1a-45b0-4e4c-bd96-f0632d761a1f.zip
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Plenamine LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINE B. Braun Medical Inc. a3244d1a-45b0-4e4c-bd96-f0632d761a1f 2026-05-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091112 application number: ANDA091112 ndc (product): 0264-4500
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1601982 Plenamine 15 % Injectable Solution PSN a3244d1a-45b0-4e4c-bd96-f0632d761a1f 9 1601982 alanine 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] SBD a3244d1a-45b0-4e4c-bd96-f0632d761a1f 9 800584 alanine 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 SCD a3244d1a-45b0-4e4c-bd96-f0632d761a1f 9 1601982 Plenamine 15 % Amino Acids Injection SY a3244d1a-45b0-4e4c-bd96-f0632d761a1f 9
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0264-4500-00 00264450000 8 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINER 8 container 2018-09-28 0000-00-00 No No Current 0264-4500-05 00264450005 4 CONTAINER in 1 CASE (0264-4500-05) / 2000 mL in 1 CONTAINER 4 container 2019-10-29 0000-00-00 No No Current