Additive Formula 3
- Product NDC
- 14537-828
- Requested package NDC
- 14537-828-35
- 11-digit product format
- 145370828
- Labeler code
- 14537
- Product ID
- 14537-828_3973708b-e5a7-47f5-829c-5e3ae9620dd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, and Adenine
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Terumo BCT, Ltd
- Application
- BN001214
- Marketing category
- NDA
- Marketing start
- 2002-05-29
- Marketing end
- 0000-00-00
- Substance
- DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; CITRIC ACID MONOHYDRATE; ADENINE
- Active strength
- 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
- Pharmacologic classes
- Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 | 14537-828 | 14537-828-35 | D | Discontinued by firm | 2026-10-05 |
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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 14537-828 | 14537-828-35 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 14537-828 | 14537-828-35 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 14537-828 | 14537-828-35 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 14537-828 | ADDITIVE FORMULA 3 (DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINE) SOLUTION [TERUMO BCT, LTD] | 3 | Legacy NDC | 20250124_3a084ab2-354c-4975-a100-dffa8e4724b2.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 |
|---|---|---|---|---|---|---|
| Additive Formula 3 | DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINE | Terumo BCT, Ltd | 9a5247a1-cc05-442d-b2d0-950f887f03c2 | 2026-01-30 | Warnings, Adverse reactions | BN001214 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 14537-828-35 | 14537082835 | 24 BAG in 1 CARTON (14537-828-35) > 350 mL in 1 BAG | 24 bag | 2002-05-29 | 0000-00-00 | No | No | Current |