calcium chloride

Product NDC: 0121-1099
11-digit product format: 001211099
Labeler code: 0121
Product ID: 0121-1099_917fd418-9deb-481b-bc64-803a2d28a865
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: calcium chloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA217463
Marketing category: ANDA
Marketing start: 2026-10-12
Substance: CALCIUM CHLORIDE
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217463-001	CALCIUM CHLORIDE 10%	CALCIUM CHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP		2025-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217463-001	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	A217463-001	CALCIUM CHLORIDE 10%	100MG/ML	INJECTABLE / INJECTION	AP	2025-09-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217463-001	CALCIUM CHLORIDE 10%	100MG/ML	INJECTABLE / INJECTION	AP	2025-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217463-001	CALCIUM CHLORIDE 10%	100MG/ML	INJECTABLE / INJECTION	AP	2025-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217463-001	CALCIUM CHLORIDE 10%	100MG/ML	INJECTABLE / INJECTION	AP	2025-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217463-001	CALCIUM CHLORIDE 10%	100MG/ML	INJECTABLE / INJECTION	AP	2025-09-29	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217463-001	CALCIUM CHLORIDE 10%	100MG/ML	INJECTABLE / INJECTION	AP	2025-09-29	`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	A217463-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217463-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217463-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217463-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217463-001	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217463-001	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 chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCIUM CHLORIDE	100 mg/mL

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 chloride	CALCIUM CHLORIDE	Eskayef Pharmaceuticals Limited	5b0bd762-4c87-597e-e063-6394a90a8303	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217463 application number: ANDA217463
calcium chloride	CALCIUM CHLORIDE	SQUARE PHARMACEUTICALS PLC.	753c3973-6522-4d33-811b-b63a4e8cc585	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217463 application number: ANDA217463

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M4I0D6VV5M	CALCIUM CHLORIDE	10035-04-8	CALCIUM CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0121-1099-02	00121109902	10 VIAL in 1 CARTON (0121-1099-02) / 10 mL in 1 VIAL (0121-1099-55)	10 vial	2026-10-12	No	No	Current