Home DailyMed e0d003a5-0abe-4fc8-8569-a372ada57acf National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:55:25
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 44 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N016822-001 FREAMINE 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 N016822-002 FREAMINE II 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 N016822-003 FREAMINE III 3% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION Approved before 1982 N016822-004 FREAMINE III 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 N016822-005 FREAMINE III 10% AMINO ACIDS 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 N016822-006 FREAMINE HBC 6.9% AMINO ACIDS 6.9% (6.9GM/100ML) INJECTABLE / INJECTION 1983-05-17 N016822-007 FREAMINE III 8.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML INJECTABLE / INJECTION 1988-07-01
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 8 · 308 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 2026-10-15 13:18:30 2026-09 N016822-001 FREAMINE 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N016822-002 FREAMINE II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N016822-003 FREAMINE III 3% W/ ELECTROLYTES 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N016822-004 FREAMINE III 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N016822-005 FREAMINE III 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N016822-006 FREAMINE HBC 6.9% 6.9% (6.9GM/100ML) INJECTABLE / INJECTION 1983-05-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N016822-007 FREAMINE III 8.5% W/ ELECTROLYTES 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML INJECTABLE / INJECTION 1988-07-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 N016822-001 FREAMINE 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N016822-002 FREAMINE II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N016822-003 FREAMINE III 3% W/ ELECTROLYTES 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N016822-004 FREAMINE III 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N016822-005 FREAMINE III 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N016822-006 FREAMINE HBC 6.9% 6.9% (6.9GM/100ML) INJECTABLE / INJECTION 1983-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N016822-007 FREAMINE III 8.5% W/ ELECTROLYTES 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML INJECTABLE / INJECTION 1988-07-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N016822-001 FREAMINE 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016822-002 FREAMINE II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016822-003 FREAMINE III 3% W/ ELECTROLYTES 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016822-004 FREAMINE III 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016822-005 FREAMINE III 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016822-006 FREAMINE HBC 6.9% 6.9% (6.9GM/100ML) INJECTABLE / INJECTION 1983-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016822-007 FREAMINE III 8.5% W/ ELECTROLYTES 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML INJECTABLE / INJECTION 1988-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N016822-001 FREAMINE 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016822-002 FREAMINE II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016822-003 FREAMINE III 3% W/ ELECTROLYTES 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016822-004 FREAMINE III 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016822-005 FREAMINE III 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016822-006 FREAMINE HBC 6.9% 6.9% (6.9GM/100ML) INJECTABLE / INJECTION 1983-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016822-007 FREAMINE III 8.5% W/ ELECTROLYTES 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML INJECTABLE / INJECTION 1988-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016822-001 FREAMINE 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016822-002 FREAMINE II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016822-003 FREAMINE III 3% W/ ELECTROLYTES 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016822-004 FREAMINE III 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016822-005 FREAMINE III 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016822-006 FREAMINE HBC 6.9% 6.9% (6.9GM/100ML) INJECTABLE / INJECTION 1983-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016822-007 FREAMINE III 8.5% W/ ELECTROLYTES 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML INJECTABLE / INJECTION 1988-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N016822-001 FREAMINE 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016822-002 FREAMINE II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016822-003 FREAMINE III 3% W/ ELECTROLYTES 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016822-004 FREAMINE III 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016822-005 FREAMINE III 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.