INDIUM IN 111 CHLORIDE

Manufacturer: Curium US LLC
Effective date: 2019-12-19
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 23:49:46

Label at a glance#

ProductINDIUM IN 111 CHLORIDE

Active ingredientINDIUM CHLORIDE IN-111

Label structure10 sections

Indications and uses

Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint preparations used for in vivo diagnostic imaging procedures. It is also indicated for radiolabeling Zevalin preparations used for Radioimmunotherapy procedures. Please refer to the package insert for ProstaScint or Zevalin for information on the final drug product.

Dosage and administration

Radiation Dosimetry Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Contacts and useful links#

PhoneLabel contact1-866-789-2211

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint™ preparations used for in vivo diagnostic imaging procedures. It is also indicated for radiolabeling Zevalin™ preparations used for Radioimmunotherapy procedures. It is supplied as a sterile, non-pyrogenic solution of Indium In 111 Chloride in 0.05 molar hydrochloric acid. No carrier has been added to the solution. Each 0.5 milliliter of the solution contains 185 megabequerels (5 millicuries) of Indium In 111 Chloride at time of calibration (specific activity of >1.85 GBq/μg Indium; >50 mCi/μg Indium at this time of calibration). The solution pH is 1.1 to 1.4.

Radionuclidic Purity

SPL UNCLASSIFIED SECTION

Indium In-111 is cyclotron produced by the proton irradiation ((p,2n) reaction) of cadmium Cd-112 enriched target. At time of calibration, it contains not less than 99.925% indium In-111 and, not more than 0.075% indium In-114m and zinc Zn-65 combined. At the time of expiration, it contains not less than 99.85% indium 111 and not more than 0.15% indium In-114m and zinc Zn-65 combined. No carrier has been added.

Radiochemical Purity

SPL UNCLASSIFIED SECTION

At the time of calibration, the Indium In 111 Chloride Sterile Solution contains not less than 95% of the Indium present as ionic In³⁺.

Chemical Purity

SPL UNCLASSIFIED SECTION

Indium In 111 Chloride Sterile Solution is tested for the following metallic impurities: copper, iron, cadmium, lead, zinc, nickel, and mercury, and contains extremely low levels of these metals. The sum of the individual impurity ratios for the metals listed is not more than 0.60 ppm.

Physical Characteristics

SPL UNCLASSIFIED SECTION

Indium In-111 decays by electron capture to cadmium Cd-111 (stable) with a physical half-life of 67.32 hours (2.81 days) (see Table 2)¹. Photons useful for detection and imaging are listed in Table 1.

Table 1. Principal Radiation Emission Data^*
Radiation	Mean Percent Per Disintegration	Mean Energy (keV)
^*Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026, 115 (1981).
Gamma-2	90.2	171.3
Gamma-3	94.0	245.4

1 From Radiopharmaceutical Internal Dosimetry Information Center, Oak Ridge Associated Universities, Oak Ridge, TN 37831-0117, February 1985.

External Radiation

SPL UNCLASSIFIED SECTION

The exposure rate constant for 37 MBq (1 mCi) of indium In-111 is 8.3 x 10^-4 C/kg/hr (3.21 R/hr) at 1 cm. The specific gamma ray constant for indium In-111 is 3.21 R/hr-mCi @ 1 cm¹. The first half-value thickness of lead (Pb) is 0.023 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.834 cm of Pb will decrease the external radiation exposure by a factor of about 1000.

Table 2. Indium In-111 Radiation Attenuation by Lead Shielding
Shield Thickness (Pb) cm	Coefficient of Attenuation
0.023	0.5
0.203	10^-1
0.513	10^-2
0.834	10^-3
1.12	10^-4

These estimates of attenuation do not take into consideration the presence of longer-lived contaminants with higher energy photons, namely indium In-114m.

To correct for physical decay of indium In-111, the fractions that remain at selected intervals before and after calibration time are shown in Table 3.

Table 3. Indium In-111 Physical Decay Chart; Half-Life 67.32 hours (2.81 days)
* Calibration time
Hours	Fraction Remaining	Hours	Fraction Remaining
-72	2.10	0*	1.00
-60	1.85	6	0.94
-48	1.64	12	0.88
-36	1.45	24	0.78
-24	1.28	36	0.69
-12	1.13	48	0.61
-6	1.06	72	0.48

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

WARNINGS

WARNINGS SECTION

CONTENTS OF THE VIAL OF INDIUM In 111 CHLORIDE SOLUTION ARE INTENDED ONLY TO BE USED AS AN INGREDIENT FOR RADIOLABELING PROSTASCINT FOR USE IN IN VIVO DIAGNOSTIC IMAGING PROCEDURES OR TO BE USED AS AN INGREDIENT FOR RADIOLABELING ZEVALIN™ FOR USE IN RADIOIMMUNOTHERAPY PROCEDURES, AND ARE NOT TO BE ADMINISTERED DIRECTLY TO HUMANS.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Caution must be used to maintain proper aseptic technique while withdrawing and transferring contents of the Indium Chloride solution vial.

Do not use after expiration time and date indicated on vial label.

Contents of the vial are radioactive and adequate shielding and handling precautions must be maintained at all times.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Pregnancy Category

PREGNANCY SECTION

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Nursing Mothers

NURSING MOTHERS SECTION

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Pediatric Use

PEDIATRIC USE SECTION

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Radiation Dosimetry

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

HOW SUPPLIED

HOW SUPPLIED SECTION

Indium In 111 Chloride Sterile Solution is supplied in 10 mL vials containing 0.5 mL of solution. It is a sterile non-pyrogenic solution in 0.05 molar hydrochloric acid. No carrier is added to the solution. Each 0.5 mL contains 185 megabequerels (5 millicuries) of Indium In 111 Chloride at time of calibration. The pH of the solution is 1.1 to 1.4.

Special Storage and Handling

The contents of the vial are radioactive and adequate shielding and handling precautions must be maintained. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Storage and disposal of Indium In 111 Chloride Sterile Solution should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of the radionuclide.

The vial should be kept inside its transportation shield whenever possible and should be handled with forceps when contents are being removed.

Pharmacovigilance:1-866-789-2211

ProstaScint is a trademark of EUSA Pharma (USA), Inc.
Zevalin is a trademark of RIT Oncology, LLC.

Curium and the Curium logo are trademarks of a Curium company.
©2018 Curium US LLC. All Rights Reserved.

Manufactured by:
Curium US LLC
Maryland Heights, MO 63043

Made in USA

A132I0

R12/2018

CURIUM^TM

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Indium In 111 Chloride Sterile Solution

Sterile, Non-Pyrogenic Solution
Contains no Bacteriostatic Preservative
Store at Controlled Room Temperature 20° to 25°C (68° to 77°F)

SINGLE DOSE - NOT FOR DIRECT ADMINISTRATION
NO CARRIER ADDED
FOR USE ONLY IN RADIOLABELING
ProstaScint™ (Capromab Pendetide),
and Zevalin™ (Ibritumomab Tiuxetan)
SEE PACKAGE INSERT FOR INFORMATION

Rx only

WARNING: Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within heavier shield.

Manufactured by:
Curium US LLC
Maryland Heights, MO 63043
Made in USA

CURIUM^TM

CAUTION RADIOACTIVE MATERIAL

A132C0

R12/2018

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
INDIUM CHLORIDE IN-111	ACTIVE INGREDIENT	58TD96H03I	1
INDIUM CATION IN-111	ACTIVE MOIETY	WJZ06C0H8L	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

INDIUM IN 111 CHLORIDE
INDIUM CHLORIDE IN-111
INDIUM CATION IN-111
HYDROCHLORIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69945-132	69945-132-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
INDIUM CHLORIDE IN-111	58TD96H03I	ACTIM
HYDROCHLORIC ACID	QTT17582CB	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 148 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	TABLET / ORAL	2.32 mg		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	EMULSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SYRUP / ORAL	2.03 mg/1ml		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / EXTRACORPOREAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, EMULSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / SUBCONJUNCTIVAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SPRAY, METERED / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INFILTRATION	0.37 %w/v		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	LIQUID / ORAL	4.46 mg/1ml		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / PERINEURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / ORAL		223 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / OPHTHALMIC	0.31 %w/v		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / NASAL	91.7 mg/100ml		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SPRAY, METERED / NASAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRAVITREAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	POWDER, FOR SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION, EXTENDED RELEASE / ORAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRASPINAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRAVESICAL		157 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / RETROBULBAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	LOTION / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / DENTAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	DROPS / NASAL	10 ml		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SPRAY / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, EMULSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	GEL / TOPICAL		10 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, EMULSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N019841-001	INDIUM IN 111 CHLORIDE	INDIUM IN-111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION		RLD	1994-09-27

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD	1994-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019841-001	INDIUM IN 111 CHLORIDE	5mCi/0.5ML	INJECTABLE / INJECTION	RLD, RS	1994-09-27	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
228d5e04-0d29-5723-e063-6394a90af331			e07e66ef-fb9e-4f9f-b63f-ab28f622cb2e	2024-09-20	Warnings, Adverse reactions	Exact identifier spl set id: e07e66ef-fb9e-4f9f-b63f-ab28f622cb2e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.