Calcium Gluconate
- Product NDC
- 65145-172
- 11-digit product format
- 651450172
- Labeler code
- 65145
- Product ID
- 65145-172_f28e9871-d546-4b48-ac3d-aead0d4c0449
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcium Gluconate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Caplin Steriles Limited
- Application
- ANDA218840
- Marketing category
- ANDA
- Marketing start
- 2026-05-13
- Substance
- CALCIUM GLUCONATE MONOHYDRATE
- Active strength
- 100 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calcium Gluconate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CALCIUM GLUCONATE MONOHYDRATE | 100 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | CZN0MI5R31 |
| Rxcui | 197435, 1668248, 1668250 |
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 |
|---|---|---|---|---|---|---|
| 65145-172-01 | Calcium Gluconate | 100 mL in 1 VIAL, PLASTIC | INJECTION, SOLUTION | 100 | 1 | |
| 65145-172-20 | Calcium Gluconate | 20 in 1 CARTON | INJECTION, SOLUTION | 20 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1668250 | calcium gluconate 1 GM in 10 ML (10 % ) Injection | PSN | f28e9871-d546-4b48-ac3d-aead0d4c0449 | 1 |
| 197435 | calcium gluconate 100 MG/ML (10 % ) Injectable Solution | PSN | f28e9871-d546-4b48-ac3d-aead0d4c0449 | 1 |
| 1668248 | calcium gluconate 5 GM in 50 ML (10 % ) Injection | PSN | f28e9871-d546-4b48-ac3d-aead0d4c0449 | 1 |
| 1668250 | 10 ML calcium gluconate 100 MG/ML Injection | SCD | f28e9871-d546-4b48-ac3d-aead0d4c0449 | 1 |
| 1668248 | 50 ML calcium gluconate 100 MG/ML Injection | SCD | f28e9871-d546-4b48-ac3d-aead0d4c0449 | 1 |
| 197435 | calcium gluconate 100 MG/ML Injectable Solution | SCD | f28e9871-d546-4b48-ac3d-aead0d4c0449 | 1 |
| 197435 | calcium gluconate 10 % Injectable Solution | SY | f28e9871-d546-4b48-ac3d-aead0d4c0449 | 1 |
| 1668250 | calcium gluconate 10 % per 10 ML Injection | SY | f28e9871-d546-4b48-ac3d-aead0d4c0449 | 1 |
| 1668248 | calcium gluconate 10 % per 50 ML Injection | SY | f28e9871-d546-4b48-ac3d-aead0d4c0449 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65145-172-01 | 65145017201 | 100 mL in 1 VIAL, PLASTIC | 100 ml | Historical | |||
| 65145-172-20 | 65145017220 | 20 VIAL, PLASTIC in 1 CARTON (65145-172-20) / 100 mL in 1 VIAL, PLASTIC (65145-172-01) | 2026-05-13 | No | No | Historical |