Paromomycin Sulfate Capsules, USP

Manufacturer: Sun Pharmaceutical Industries, Inc.
Effective date: 2016-02-03
Label type: Human Prescription Drug Label
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:29:14

Label at a glance#

ProductParomomycin Sulfate

Active ingredientPAROMOMYCIN SULFATE

Label structure9 sections

Indications and uses

Paromomycin sulfate is indicated for intestinal amebiasis—acute and chronic (NOTE—It is not effective in extraintestinal amebiasis); management of hepatic coma—as adjunctive therapy.

Dosage and administration

Intestinal amebiasis: Adults and Children: Usual dose—25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days. Management of hepatic coma: Adults: Usual dose—4 g daily in divided doses, given at regular intervals for five to six days.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Paromomycin sulfate is a broad spectrum antibiotic produced by Streptomyces riomosus var. paromomycinus. It is a white, amorphous, stable, water-soluble product. Paromomycin sulfate is designated chemically as O-2,6-Diamino-2,6-dideoxy-β-L-idopyranosyl-(1→3)-O-β-D- ribofuranosyl-(1→5)-O-[2-amino-2-deoxy-α-D-glucopyranosyl-(1→4)]-2-deoxystreptamine sulfate (salt). The molecular formula is C₂₃H₄₅N₅O₁₄ • xH₂SO₄, with a molecular weight of 615.64 (base). Its structural formula is:

Each capsule, for oral administration, contains paromomycin sulfate equivalent to 250 mg paromomycin. Each capsule also contains the following inactive ingredients: FD&C Green #3; FD&C Yellow #5 (tartrazine); gelatin, NF; and titanium dioxide, USP.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

The in vitro and in vivo antibacterial action of paromomycin closely parallels that of neomycin. It is poorly absorbed after oral administration, with almost 100% of the drug recoverable in the stool.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Paromomycin sulfate is indicated for intestinal amebiasis—acute and chronic (NOTE—It is not effective in extraintestinal amebiasis); management of hepatic coma—as adjunctive therapy.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. It is also contraindicated in intestinal obstruction.

PRECAUTIONS

PRECAUTIONS SECTION

The use of this antibiotic, as with other antibiotics, may result in an overgrowth of nonsusceptible organisms, including fungi. Constant observation of the patient is essential. If new infections caused by nonsusceptible organisms appear during therapy, appropriate measures should be taken.

The drug should be used with caution in individuals with ulcerative lesions of the bowel to avoid renal toxicity through inadvertent absorption.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Intestinal amebiasis: Adults and Children: Usual dose—25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days.

Management of hepatic coma: Adults: Usual dose—4 g daily in divided doses, given at regular intervals for five to six days.

HOW SUPPLIED

HOW SUPPLIED SECTION

Paromomycin Sulfate Capsules, each contain paromomycin sulfate equivalent to 250 mg paromomycin. The capsule is green/yellow, imprinted "175" in black ink on the cap and body.

NDC 57664-175-08: Bottles of 100

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Protect from moisture.

Caution—Federal law prohibits dispensing without prescription.

Manufactured by:

ALKALOIDA Chemical Company Zrt.
4440 Tiszavasvári

Kabay János u. 29.

Hungary

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Revised: 04/2015

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Paromomycin Capsules, USP 250 mg
NDC 57664-175-08
Rx Only
100 Tablets
ALKALOIDA Chemical Company Zrt.

Paromomycinsulfate-250mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-175-08	EA - Each	57664-175	456d8346-eaaf-4b8d-848d-1251d32e8a31	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PAROMOMYCIN SULFATE	ACTIVE INGREDIENT	845NU6GJPS	2
PAROMOMYCIN	ACTIVE MOIETY	61JJC8N5ZK	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Paromomycin Sulfate
PAROMOMYCIN
FD&C GREEN NO. 3
FD&C YELLOW NO. 5
GELATIN
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57664-175	57664-175-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PAROMOMYCIN SULFATE	845NU6GJPS	ACTIB
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
GELATIN	2G86QN327L	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 · 121 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, EXTENDED RELEASE / ORAL		1229 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	ELIXIR / ORAL	0.15 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SYRUP / ORAL	3.75 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / ORAL	1 mg/1ml		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, COATED / ORAL	7.93 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRAMUSCULAR	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / ORAL	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	PASTILLE / ORAL	143 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	TABLET, COATED / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE, EXTENDED RELEASE / ORAL	0.26 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / SUBCUTANEOUS	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	ELIXIR / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	DROPS / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / RESPIRATORY (INHALATION)	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, EXTENDED RELEASE / ORAL	0.16 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	ELIXIR / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / ORAL		120 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SYSTEM / TOPICAL		1050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / ORAL	180 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SHAMPOO / TOPICAL	0.09 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRAVENOUS	20 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, CHEWABLE / ORAL	4.5 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LIQUID / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, CHEWABLE / ORAL		24 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	TABLET / ORAL		240 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 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
A064171-001	PAROMOMYCIN SULFATE	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL			1997-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064171-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA	RS	1997-06-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064171-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064171-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064171-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064171-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064171-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064171-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064171-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064171-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064171-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064171-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064171-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064171-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064171-001	AA	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064171-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064171-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064171-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064171-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064171-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064171-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064171-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064171-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064171-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064171-001	AA	1	`cb3db0bc1861…`

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
771c4311-f5f3-452d-9b12-6db1ec888c9e			22494bde-a53e-4b3c-a89b-0ccda341f28f	2019-12-13	Adverse reactions	Exact identifier spl set id: 22494bde-a53e-4b3c-a89b-0ccda341f28f

Reported adverse events (FAERS/openFDA)#

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