CALCIUM GLUCONATE
- Product NDC
- 80830-2362
- 11-digit product format
- 808302362
- Labeler code
- 80830
- Product ID
- 80830-2362_2bd614b6-02ce-49e3-86e2-dfaec7a13e04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- calcium gluconate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Amneal Pharmaceuticals Private Limited
- Application
- ANDA217174
- Marketing category
- ANDA
- Marketing start
- 2023-09-08
- Substance
- CALCIUM GLUCONATE MONOHYDRATE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2023-09-05 |
| A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2023-09-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217174-001 | AP |
| A217174-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2023-09-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2023-09-05 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2023-09-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RS | 2023-09-05 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | RS | 2023-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RS | 2023-09-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217174-001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217174-002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-09-05 | 9b2671bbb829… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A217174-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217174-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217174-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217174-002 | AP | 1 | 011fe1cb6892… |
| 2025-08-23 18:47 UTC | 2025-08 | A217174-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217174-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217174-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217174-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217174-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217174-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217174-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217174-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217174-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217174-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217174-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217174-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217174-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217174-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217174-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217174-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217174-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217174-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217174-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217174-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217174-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217174-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217174-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A217174-002 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217174-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217174-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A217174-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A217174-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A217174-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A217174-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217174-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217174-002 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217174-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217174-002 | AP | 1 | 9b2671bbb829… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217174-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217174-002 | AP | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217174-001 | CGT | 2024-03-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217174-002 | CGT | 2024-03-10 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217174-001 | CGT | 2024-03-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217174-002 | CGT | 2024-03-10 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217174-001 | CGT | 2024-03-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217174-002 | CGT | 2024-03-10 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217174-001 | CGT | 2024-03-10 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217174-002 | CGT | 2024-03-10 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217174-001 | CGT | 2024-03-10 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217174-002 | CGT | 2024-03-10 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217174-001 | CGT | 2024-03-10 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217174-002 | CGT | 2024-03-10 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217174-001 | CGT | 2024-03-10 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217174-002 | CGT | 2024-03-10 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217174-001 | CGT | 2024-03-10 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217174-002 | CGT | 2024-03-10 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217174-001 | CGT | 2024-03-10 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A217174-002 | CGT | 2024-03-10 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217174-001 | CGT | 2024-03-10 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217174-002 | CGT | 2024-03-10 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A217174-001 | CGT | 2024-03-10 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A217174-002 | CGT | 2024-03-10 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A217174-001 | CGT | 2024-03-10 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A217174-002 | CGT | 2024-03-10 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217174-001 | CGT | 2024-03-10 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217174-002 | CGT | 2024-03-10 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217174-001 | CGT | 2024-03-10 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217174-002 | CGT | 2024-03-10 | 9b2671bbb829… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CALCIUM GLUCONATE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CALCIUM GLUCONATE MONOHYDRATE | 20 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| CZN0MI5R31 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ee79b4c-21d3-4742-ae37-e2f562917706 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bee4fa8d-8d82-423a-a0b5-40a89dd13a99 | Product name | 1 | 20250618 |
| e0d2eb29-08bd-4bba-90d1-c91c68a38767 | Product name | 4 | 20250516 |
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 334fe8d2-68fb-4331-a576-420e302ec069 | Product name | 7 | 20240320 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| e92765c1-be81-432a-b909-1b10777ec378 | Product name | 1 | 20190208 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 0441a8f5-3835-497c-aedd-bc78cba56b2a | Product name | 1 | 20150317 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80830-2362-2 | CALCIUM GLUCONATE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | 16 | |
| 80830-2362-2 | CALCIUM GLUCONATE | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | 16 | |
| 80830-2362-9 | CALCIUM GLUCONATE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | 16 | |
| 80830-2362-9 | CALCIUM GLUCONATE | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80830-2362-1 | ML - Milliliter | 80830-2362 | 524698a9-3393-49af-bcea-bf627129372e | 1 | 2023-10-16 |
| 80830-2362-2 | ML - Milliliter | 80830-2362 | 11a84e08-0912-4795-870a-a97789a50ba9 | 1 | 2024-02-14 |
| 80830-2362-9 | ML - Milliliter | 80830-2362 | b029b26f-0c6c-45a1-98ea-8da2e2e58f5e | 1 | 2023-10-16 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80830-2362 | CALCIUM GLUCONATE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] | 16 | Current NDC, 4 package rows | 20250522_8ee79b4c-21d3-4742-ae37-e2f562917706.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 |
|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | Amneal Pharmaceuticals Private Limited | 8ee79b4c-21d3-4742-ae37-e2f562917706 | 2024-04-18 | Warnings, Adverse reactions | 217174 ANDA217174 80830-2362 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2117610 | calcium gluconate 1000 MG in 50 mL Injection | PSN | 8ee79b4c-21d3-4742-ae37-e2f562917706 | 16 |
| 2117608 | calcium gluconate 2000 MG in 100 ML Injection | PSN | 8ee79b4c-21d3-4742-ae37-e2f562917706 | 16 |
| 2117608 | 100 ML calcium gluconate 20 MG/ML Injection | SCD | 8ee79b4c-21d3-4742-ae37-e2f562917706 | 16 |
| 2117610 | 50 ML calcium gluconate 20 MG/ML Injection | SCD | 8ee79b4c-21d3-4742-ae37-e2f562917706 | 16 |
| 2117610 | calcium gluconate 1000 MG per 50 ML Injection | SY | 8ee79b4c-21d3-4742-ae37-e2f562917706 | 16 |
| 2117608 | calcium gluconate 2000 MG per 100 ML Injection | SY | 8ee79b4c-21d3-4742-ae37-e2f562917706 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80830-2362-2 | 80830236202 | 12 POUCH in 1 CARTON (80830-2362-2) / 1 BAG in 1 POUCH / 50 mL in 1 BAG | 12 pouch | 2023-11-08 | No | No | Current |
| 80830-2362-9 | 80830236209 | 24 POUCH in 1 CARTON (80830-2362-9) / 1 BAG in 1 POUCH / 50 mL in 1 BAG | 24 pouch | 2023-09-08 | No | No | Current |