Calcium Gluconate
- Product NDC
- 50090-3398
- 11-digit product format
- 500903398
- Labeler code
- 50090
- Product ID
- 50090-3398_986ef76b-51ee-4ea6-aa6b-55abb5d1af24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcium Gluconate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- A-S Medication Solutions
- Application
- NDA208418
- Marketing category
- NDA
- Marketing start
- 2017-06-15
- Marketing end
- 0000-00-00
- Substance
- CALCIUM GLUCONATE MONOHYDRATE
- Active strength
- 98 mg/mL
- Pharmacologic classes
- Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-3398-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-e4ea-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION. CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-3398-0 | Calcium Gluconate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 1 | |
| 50090-3398-0 | Calcium Gluconate | 10 mL in 1 VIAL, PLASTIC | INJECTION, SOLUTION | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-3398-0 | ML - Milliliter | 50090-3398 | e4b6d4ba-2cdf-4666-a2ea-baec2d1f2d12 | 1 | 2019-05-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3398 | CALCIUM GLUCONATE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20190205_d98cdf54-0dce-459f-881f-3b6c6e6185fe.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1668250 | calcium gluconate 1 GM in 10 ML (10 % ) Injection | PSN | d98cdf54-0dce-459f-881f-3b6c6e6185fe | 1 |
| 1668250 | 10 ML calcium gluconate 100 MG/ML Injection | SCD | d98cdf54-0dce-459f-881f-3b6c6e6185fe | 1 |
| 1668250 | calcium gluconate 10 % per 10 ML Injection | SY | d98cdf54-0dce-459f-881f-3b6c6e6185fe | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-3398-0 | 50090339800 | 25 VIAL, PLASTIC in 1 TRAY (50090-3398-0) > 10 mL in 1 VIAL, PLASTIC | 2018-03-14 | 0000-00-00 | No | No | Current |