Paromomycin Sulfate

Product NDC
76413-147
11-digit product format
764130147
Labeler code
76413
Product ID
76413-147_4412d832-f7b5-445d-a0ba-44954389f4d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paromomycin Sulfate
Dosage form
CAPSULE
Route
ORAL
Labeler
Central Texas Community Health Centers
Application
ANDA065173
Marketing category
ANDA
Marketing start
2009-10-22
Marketing end
0000-00-00
Substance
PAROMOMYCIN SULFATE
Active strength
250 mg/1
Pharmacologic classes
Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76413-147IInactivated by FDA2026-08-11
excluded packagepackage76413-14776413-147-01IInactivated by FDA2026-08-11
excluded packagepackage76413-14776413-147-21IInactivated by FDA2026-08-11
excluded packagepackage76413-14776413-147-42IInactivated by FDA2026-08-11
excluded packagepackage76413-14776413-147-63IInactivated by FDA2026-08-11

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 2 · 105 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-147-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-147-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-147-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-147-63d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-147-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-147-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-147-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-147-63f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-147-422ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-147-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-147-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-147-632ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-147-42a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-147-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-147-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-147-63a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-147-42cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-147-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-147-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-147-63cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-147-42cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-147-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-147-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-147-63cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-147-42302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-147-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-147-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-147-63302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-147-42ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-147-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-147-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-147-63ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-147-420efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-147-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-147-210efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-147-630efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-147-42ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-147-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-147-21ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-147-63ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76413-147-42367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76413-147-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76413-147-21367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76413-147-63367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76413-147-42557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76413-147-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76413-147-21557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76413-147-63557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065173-001PAROMOMYCIN SULFATEPAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-14

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-143f01610625f2…
2019-09-15 20:21 UTC2019-09A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALRS2007-12-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065173-001PAROMOMYCIN SULFATEEQ 250MG BASECAPSULE / ORALAA2007-12-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065173-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065173-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065173-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065173-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065173-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065173-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065173-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A065173-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065173-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065173-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065173-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A065173-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065173-001AA1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065173-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065173-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065173-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065173-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065173-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065173-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065173-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065173-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065173-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065173-001AA1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-147-01Paromomycin Sulfate1 in 1 BOTTLECAPSULE12
76413-147-21Paromomycin Sulfate21 in 1 BOTTLECAPSULE212
76413-147-42Paromomycin Sulfate42 in 1 BOTTLECAPSULE422
76413-147-63Paromomycin Sulfate63 in 1 BOTTLECAPSULE632

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-147PAROMOMYCIN SULFATE CAPSULE [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]2Legacy NDC, 4 package rows20171121_333d55f0-ab49-459e-8d32-1590b2623ef3.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HumatinPAROMOMYCIN SULFATEWaylis Therapeutics LLCa725f022-ec3c-430d-8021-96c861b9893c2025-11-13Adverse reactionsExact identifier
application applno (ANDA): 065173
application number: ANDA065173

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314184paromomycin sulfate 250 MG Oral CapsulePSN333d55f0-ab49-459e-8d32-1590b2623ef32
314184paromomycin 250 MG Oral CapsuleSCD333d55f0-ab49-459e-8d32-1590b2623ef32
314184paromomycin (as paromomycin sulfate) 250 MG Oral CapsuleSY333d55f0-ab49-459e-8d32-1590b2623ef32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-147-01764130147011 in 1 BOTTLEHistorical
76413-147-217641301472121 in 1 BOTTLEHistorical
76413-147-427641301474242 in 1 BOTTLEHistorical
76413-147-637641301476363 in 1 BOTTLEHistorical