Perikabiven
- Product NDC
- 63323-714
- 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
- DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE
- Active strength
- 7.5; 3.5; 170; 124; 105; 68; 20; 187; 164; 164; 152; 141; 116; 116; 116; 40; 333; 235; 164; 141; 116; 94; 71; 4.8 g/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; mg/100mL; mg/100mL; mg/100mL; mg/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#
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63323-714 | 63323-714-24 | D | Discontinued by firm | 2026-09-14 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 2014-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 2014-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 2014-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 2014-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 2014-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | 2014-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | 2014-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | 2014-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | 2014-08-25 | fd3edfee7708… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N200656-001 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200656-002 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200656-003 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200656-004 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200656-005 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200656-006 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200656-007 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N200656-001 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200656-002 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200656-003 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200656-004 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200656-005 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200656-006 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200656-007 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200656-001 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200656-002 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200656-003 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200656-004 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200656-005 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200656-006 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200656-007 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200656-001 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200656-002 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200656-003 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200656-004 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200656-005 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200656-006 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200656-007 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200656-001 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200656-002 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200656-003 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200656-004 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200656-005 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200656-006 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200656-007 | 12390398 | 2036-05-03 | Drug product | 2025-09-11 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Perikabiven
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROSE MONOHYDRATE | 7.5 g/100mL |
| SOYBEAN OIL | 3.5 g/100mL |
| SODIUM ACETATE | 170 mg/100mL |
| POTASSIUM CHLORIDE | 124 mg/100mL |
| SODIUM GLYCEROPHOSPHATE ANHYDROUS | 105 mg/100mL |
| MAGNESIUM SULFATE HEPTAHYDRATE | 68 mg/100mL |
| CALCIUM CHLORIDE | 20 mg/100mL |
| LYSINE HYDROCHLORIDE | 187 mg/100mL |
| PHENYLALANINE | 164 mg/100mL |
| LEUCINE | 164 mg/100mL |
| VALINE | 152 mg/100mL |
| HISTIDINE | 141 mg/100mL |
| THREONINE | 116 mg/100mL |
| METHIONINE | 116 mg/100mL |
| ISOLEUCINE | 116 mg/100mL |
| TRYPTOPHAN | 40 mg/100mL |
| ALANINE | 333 mg/100mL |
| ARGININE | 235 mg/100mL |
| GLYCINE | 164 mg/100mL |
| PROLINE | 141 mg/100mL |
| GLUTAMIC ACID | 116 mg/100mL |
| SERINE | 94 mg/100mL |
| ASPARTIC ACID | 71 mg/100mL |
| TYROSINE | 4.8 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 |
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.
| 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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-714-14 | 63323071414 | 1440 mL in 1 BAG (63323-714-14) | 1440 ml | 2014-08-25 | 0000-00-00 | No | No | Current |
| 63323-714-19 | 63323071419 | 1920 mL in 1 BAG (63323-714-19) | 1920 ml | 2014-08-25 | 0000-00-00 | No | No | Current |
| 63323-714-24 | 63323071424 | 2400 mL in 1 BAG (63323-714-24) | 2400 ml | 2014-08-25 | 0000-00-00 | No | No | Current |