Calcium Gluconate

Product NDC: 68462-791
Requested package NDC: 68462-791-20
11-digit product format: 684620791
Labeler code: 68462
Product ID: 68462-791_b2470072-f443-4596-ae33-1b8b0d05bc9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcium Gluconate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: GLENMARK PHARMACEUTICALS INC., USA
Application: ANDA218840
Marketing category: ANDA
Marketing start: 2026-05-04
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218840-001	CALCIUM GLUCONATE	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04
A218840-002	CALCIUM GLUCONATE	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04
A218840-003	CALCIUM GLUCONATE	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A218840-001	AP
A218840-002	AP
A218840-003	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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A218840-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218840-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218840-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218840-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218840-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218840-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218840-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218840-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218840-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218840-001	CALCIUM GLUCONATE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218840-002	CALCIUM GLUCONATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218840-003	CALCIUM GLUCONATE	10GM/100ML (100MG/ML)	SOLUTION / INTRAVENOUS	AP	2026-05-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A218840-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218840-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218840-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218840-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218840-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218840-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218840-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218840-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218840-003	AP	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218840-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218840-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218840-003	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: Calcium Gluconate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCIUM GLUCONATE MONOHYDRATE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CZN0MI5R31	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197435	Internal RxNorm lookup
1668248	Internal RxNorm lookup
1668250	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b2470072-f443-4596-ae33-1b8b0d05bc9d	Available on FDA.report

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Gluconate	CALCIUM GLUCONATE	GLENMARK PHARMACEUTICALS INC., USA	b2470072-f443-4596-ae33-1b8b0d05bc9d	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218840 application number: ANDA218840 ndc (package): 68462-791-20 ndc (product): 68462-791 ndc11 (package): 68462079120
Calcium Gluconate	CALCIUM GLUCONATE	Caplin Steriles Limited	f28e9871-d546-4b48-ac3d-aead0d4c0449	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218840 application number: ANDA218840

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CZN0MI5R31	CALCIUM GLUCONATE MONOHYDRATE	66905-23-5	CALCIUM GLUCONATE MONOHYDRATE
SQE6VB453K	CALCIUM GLUCONATE	299-28-5	Calcium Gluconate

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68462-791-20	68462079120	20 VIAL, PLASTIC in 1 CARTON (68462-791-20) / 100 mL in 1 VIAL, PLASTIC (68462-791-01)	2026-05-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Calcium Gluconate	GLENMARK PHARMACEUTICALS INC., USA \| Caplin Steriles Limited	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	1