Perikabiven
- Product NDC
- 63323-714
- Requested package NDC
- 63323-714-24
- 11-digit product format
- 633230714
- Labeler code
- 63323
- Product ID
- 63323-714_40a5c387-1b0a-4e8e-94e1-f045d7281b0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA200656
- Marketing category
- NDA
- Marketing start
- 2014-08-25
- Substance
- ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
- Active strength
- 333; 235; 71; 20; 7.5; 116; 164; 141; 116; 164; 187; 68; 116; 164; 124; 141; 94; 170; 105; 3.5; 116; 40; 4.8; 152 mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
- Pharmacologic classes
- Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63323-714 | 63323-714-24 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N200656-001 | PERIKABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | |
| N200656-002 | PERIKABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | |
| N200656-003 | PERIKABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | |
| N200656-004 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | |
| N200656-005 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | |
| N200656-006 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | |
| N200656-007 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N200656-001 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | |
| N200656-002 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | |
| N200656-003 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | |
| N200656-004 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | |
| N200656-005 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | |
| N200656-006 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | |
| N200656-007 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N200656-001 | PERIKABIVEN IN PLASTIC CONTAINER | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-002 | PERIKABIVEN IN PLASTIC CONTAINER | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-003 | PERIKABIVEN IN PLASTIC CONTAINER | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-004 | KABIVEN IN PLASTIC CONTAINER | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-005 | KABIVEN IN PLASTIC CONTAINER | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-006 | KABIVEN IN PLASTIC CONTAINER | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-007 | KABIVEN IN PLASTIC CONTAINER | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML) | EMULSION / INTRAVENOUS | RLD, RS | 2014-08-25 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N200656-001 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-002 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-003 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-004 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-005 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-006 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N200656-007 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Perikabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | c2eb5522-8572-45f4-869d-42f9fd251bb6 | 2025-09-15 | Warnings, Adverse reactions | 200656 NDA200656 63323-714-24 63323-714 63323071424 |
| Kabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | afeb4837-a759-4484-a76e-e04611c459e7 | 2025-09-11 | Warnings, Adverse reactions | 200656 NDA200656 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Perikabiven
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROSE MONOHYDRATE | 333 mg/100mL |
| SOYBEAN OIL | 235 mg/100mL |
| SODIUM ACETATE | 71 mg/100mL |
| POTASSIUM CHLORIDE | 20 mg/100mL |
| SODIUM GLYCEROPHOSPHATE ANHYDROUS | 7.5 g/100mL |
| MAGNESIUM SULFATE HEPTAHYDRATE | 116 mg/100mL |
| CALCIUM CHLORIDE | 164 mg/100mL |
| LYSINE HYDROCHLORIDE | 141 mg/100mL |
| PHENYLALANINE | 116 mg/100mL |
| LEUCINE | 164 mg/100mL |
| VALINE | 187 mg/100mL |
| HISTIDINE | 68 mg/100mL |
| THREONINE | 116 mg/100mL |
| METHIONINE | 164 mg/100mL |
| ISOLEUCINE | 124 mg/100mL |
| TRYPTOPHAN | 141 mg/100mL |
| ALANINE | 94 mg/100mL |
| ARGININE | 170 mg/100mL |
| GLYCINE | 105 mg/100mL |
| PROLINE | 3.5 g/100mL |
| GLUTAMIC ACID | 116 mg/100mL |
| SERINE | 40 mg/100mL |
| ASPARTIC ACID | 4.8 mg/100mL |
| TYROSINE | 152 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| LX22YL083G | Internal UNII lookup |
| 241ATL177A | Internal UNII lookup |
| 4550K0SC9B | Internal UNII lookup |
| 660YQ98I10 | Internal UNII lookup |
| YP1H63LJ2K | Internal UNII lookup |
| SK47B8698T | Internal UNII lookup |
| M4I0D6VV5M | Internal UNII lookup |
| JNJ23Q2COM | Internal UNII lookup |
| 47E5O17Y3R | Internal UNII lookup |
| GMW67QNF9C | Internal UNII lookup |
| HG18B9YRS7 | Internal UNII lookup |
| 4QD397987E | Internal UNII lookup |
| 2ZD004190S | Internal UNII lookup |
| AE28F7PNPL | Internal UNII lookup |
| 04Y7590D77 | Internal UNII lookup |
| 8DUH1N11BX | Internal UNII lookup |
| OF5P57N2ZX | Internal UNII lookup |
| 94ZLA3W45F | Internal UNII lookup |
| TE7660XO1C | Internal UNII lookup |
| 9DLQ4CIU6V | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c2eb5522-8572-45f4-869d-42f9fd251bb6 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-714-14 | Perikabiven | 1440 mL in 1 BAG | INJECTION, EMULSION | 1440 | 9 | |
| 63323-714-19 | Perikabiven | 1920 mL in 1 BAG | INJECTION, EMULSION | 1920 | 9 | |
| 63323-714-24 | Perikabiven | 2400 mL in 1 BAG | INJECTION, EMULSION | 2400 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-714-14 | ML - Milliliter | 63323-714 | efa5a6b9-9583-4c57-975d-01176754c596 | 1 | 2014-10-03 |
| 63323-714-19 | ML - Milliliter | 63323-714 | 602f0e18-829f-4b2c-b323-cbcd7ab4079a | 1 | 2014-10-03 |
| 63323-714-24 | ML - Milliliter | 63323-714 | 72822b73-e0f5-4dff-b0b6-e405f77ca92a | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-714 | PERIKABIVEN (DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE) INJECTION, EMULSION [FRESENIUS KABI USA, LLC ] | 8 | Current NDC, Legacy NDC, 3 package rows | 20230829_c2eb5522-8572-45f4-869d-42f9fd251bb6.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-714-24 | 63323071424 | 2400 mL in 1 BAG (63323-714-24) | 2400 ml | 2014-08-25 | 0000-00-00 | No | No | Current |