Home NDC 65145-170 Calcium Gluconate
Product NDC 65145-170
11-digit product format 651450170
Labeler code 65145
Product ID 65145-170_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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 RLD / RS 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.
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 RLD / RS Approval date Source SHA-256 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# 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65145-170-01 Calcium Gluconate 10 mL in 1 VIAL, PLASTIC INJECTION, SOLUTION 10 1 65145-170-25 Calcium Gluconate 25 in 1 CARTON INJECTION, SOLUTION 25 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65145-170-01 65145017001 10 mL in 1 VIAL, PLASTIC 10 ml Historical 65145-170-25 65145017025 25 VIAL, PLASTIC in 1 CARTON (65145-170-25) / 10 mL in 1 VIAL, PLASTIC (65145-170-01) 2026-05-13 No No Current