Leucovorin Calcium
- Product NDC
- 68083-668
- 11-digit product format
- 680830668
- Labeler code
- 68083
- Product ID
- 68083-668_782dbace-df38-43ca-b58b-ff1d89892167
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leucovorin Calcium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA218200
- Marketing category
- ANDA
- Marketing start
- 2026-10-14
- Substance
- LEUCOVORIN CALCIUM
- Active strength
- 500 mg/50mL
- Pharmacologic classes
- Folate Analog [EPC], Folic Acid [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218200-001 | LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2025-11-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218200-001 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A218200-001 | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2025-11-12 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A218200-001 | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2025-11-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A218200-001 | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2025-11-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218200-001 | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2025-11-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218200-001 | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2025-11-12 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218200-001 | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2025-11-12 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A218200-001 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A218200-001 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A218200-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218200-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218200-001 | AP | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218200-001 | AP | 1 | 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
- Leucovorin Calcium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEUCOVORIN CALCIUM | 500 mg/50mL |
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 |
|---|---|---|---|---|---|---|
| Leucovorin Calcium | LEUCOVORIN CALCIUM | GLENMARK PHARMACEUTICALS INC., USA | 79d023ab-7d77-48c1-8f47-ea322fd58c2b | 2025-12-09 | Warnings, Adverse reactions | 218200 ANDA218200 |
| Leucovorin Calcium | LEUCOVORIN CALCIUM | Gland Pharma Limited | 968b192b-72f3-41b0-a1f5-bab8a96d3419 | 2025-11-13 | Warnings, Adverse reactions | 218200 ANDA218200 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68083-668-01 | 68083066801 | 1 VIAL in 1 CARTON (68083-668-01) / 50 mL in 1 VIAL | 1 vial | 2026-10-14 | No | No | Current |