Paromomycin Sulfate

Product NDC: 23155-038
Requested package NDC: 23155-038-01
11-digit product format: 231550038
Labeler code: 23155
Product ID: 23155-038_f5c47e63-480c-4a89-a873-4fee351dc9ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paromomycin Sulfate
Dosage form: CAPSULE
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA065173
Marketing category: ANDA
Marketing start: 2009-10-22
Marketing end: 2024-03-31
Substance: PAROMOMYCIN SULFATE
Active strength: 250 mg/1
Pharmacologic classes: Antiprotozoal [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	23155-038	23155-038-01	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065173-001	PAROMOMYCIN SULFATE	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL		RS	2007-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065173-001	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE / ORAL	AA		2007-12-14	`cb3db0bc1861…`

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	A065173-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065173-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065173-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065173-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065173-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065173-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065173-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065173-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065173-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065173-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065173-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065173-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065173-001	AA	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065173-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065173-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065173-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065173-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065173-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065173-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065173-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065173-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065173-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065173-001	AA	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-038-01	EA - Each	23155-038	d9c49eaa-bfb4-4d91-8c9e-db937a701d6e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PAROMOMYCIN SULFATE	ACTIVE INGREDIENT	845NU6GJPS	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
PAROMOMYCIN	ACTIVE MOIETY	61JJC8N5ZK	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROMOMYCIN SULFATE CAPSULE [HERITAGE PHARMACEUTICALS INC.]	6

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
Humatin	PAROMOMYCIN SULFATE	Waylis Therapeutics LLC	a725f022-ec3c-430d-8021-96c861b9893c	2025-11-13	Adverse reactions	Exact identifier application applno (ANDA): 065173 application number: ANDA065173

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
845NU6GJPS	PAROMOMYCIN SULFATE	1263-89-4	PAROMOMYCIN SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314184	paromomycin sulfate 250 MG Oral Capsule	PSN	333d55f0-ab49-459e-8d32-1590b2623ef3	2
314184	paromomycin 250 MG Oral Capsule	SCD	333d55f0-ab49-459e-8d32-1590b2623ef3	2
314184	paromomycin (as paromomycin sulfate) 250 MG Oral Capsule	SY	333d55f0-ab49-459e-8d32-1590b2623ef3	2
314184	paromomycin sulfate 250 MG Oral Capsule	PSN	2b5b3dae-b406-1e2e-e054-00144ff88e88	1
314184	paromomycin 250 MG Oral Capsule	SCD	2b5b3dae-b406-1e2e-e054-00144ff88e88	1
314184	paromomycin (as paromomycin sulfate) 250 MG Oral Capsule	SY	2b5b3dae-b406-1e2e-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-038-01	23155003801	100 CAPSULE in 1 BOTTLE (23155-038-01)	100 capsule	2009-10-22	2024-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paromomycin Sulfate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	2021-12-28	HUMAN PRESCRIPTION DRUG LABEL	8
Paromomycin Sulfate Capsules, USP Rx Only	Central Texas Community Health Centers	2017-11-07	HUMAN PRESCRIPTION DRUG LABEL	2
Paromomycin Sulfate Capsules, USP Rx Only	Department of State Health Services, Pharmacy Branch	2016-02-09	HUMAN PRESCRIPTION DRUG LABEL	1