Amoxicillin

Product NDC
50090-1595
11-digit product format
500901595
Labeler code
50090
Product ID
50090-1595_a76e72f3-cc65-4fd8-93af-5fc5ffd53946
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
875 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-1595-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-1595-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-1595-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-1595-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-1595-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-1595-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-1595-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-1595-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-1595-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-1595-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-1595-08af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-1595-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-1595-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-1595-0834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-1595-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-1595-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-1595-01332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-1595-21332a3947898…d4bfe170f9cd…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065256-001AMOXICILLINAMOXICILLIN500MGTABLET / ORALAB2005-11-09
A065256-002AMOXICILLINAMOXICILLIN875MGTABLET / ORALAB2005-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065256-001AB
A065256-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065256-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065256-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065256-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065256-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065256-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065256-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065256-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065256-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065256-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065256-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065256-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065256-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065256-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065256-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065256-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065256-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065256-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065256-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN875 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
804826J2HUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308194Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aaf42367-153e-4525-af5f-f5f1c7d6c559Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-1595-02024-12-24These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
50090-1595-12024-12-24These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
50090-1595-22024-12-24These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
50090-1595-02023-01-30These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
50090-1595-12023-01-30These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
50090-1595-22023-01-30These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1595-0Amoxicillin20 in 1 BOTTLETABLET, FILM COATED2011
50090-1595-1Amoxicillin14 in 1 BOTTLETABLET, FILM COATED1411
50090-1595-2Amoxicillin30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1595-0EA - Each50090-15955a0fb3e2-aff7-4ffd-9691-6023b7353ac812021-08-05
50090-1595-1EA - Each50090-1595d98063eb-aeb0-4849-8460-4a014eb6c40f12021-09-07
50090-1595-2EA - Each50090-15950ee63419-ad6f-406b-ba3f-b7f74ccba75512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1595AMOXICILLIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 3 package rows20241226_aaf42367-153e-4525-af5f-f5f1c7d6c559.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINCoupler LLC5827b6de-6b48-d73a-e063-6394a90a4a722026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINREMEDYREPACK INC.a2c91cf0-a4e4-44c0-b712-bee63dd6c22b2026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINREMEDYREPACK INC.9618d038-e880-47f6-b8d7-bbf8ab35364d2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINREMEDYREPACK INC.f37eb415-77b2-41b0-8d20-64e821e4b05d2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINProficient Rx LP313ea909-5b1b-41ff-a0db-5aadc12e2e4f2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINCoupler LLC5037e2a5-52e9-caec-e063-6294a90ad8372026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINAmerican Health Packagingd339ea0f-8797-460f-a3b7-b8455c2503662026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.4b23e6f5-9287-4c01-b795-b8c5388330392026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.f1eee459-9021-b26e-e053-2995a90a72912026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINQPharma, Inc.2700df91-c5ef-4931-9ad7-a3c1c146ccac2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8e6f9df1-0754-69e4-e053-2a95a90acc492025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.3e4f0f03-438b-ddfb-e063-6294a90adb382025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.3880b9c2-62a5-0d23-e063-6394a90a12522025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINA-S Medication Solutionsb91f40dd-40db-473d-a399-166aeb1ce7e22025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINA-S Medication Solutionsaaf42367-153e-4525-af5f-f5f1c7d6c5592024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
ndc (product): 50090-1595
AmoxicillinAMOXICILLINBryant Ranch Prepackbef50f2a-78c6-4d0c-8ad9-cfa3c801629d2024-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.963986fc-0e59-21b0-e053-2a95a90a95312024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINA-S Medication Solutionsc3d3f94f-e976-4625-9667-3d716932f2fa2024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.20eb4ade-f3b8-db66-e063-6294a90ae8462024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINAsclemed USA, Inc.a18751fa-6202-4ae2-950a-a3f1dc9a8afd2024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSNaaf42367-153e-4525-af5f-f5f1c7d6c55911
308194amoxicillin 875 MG Oral TabletSCDaaf42367-153e-4525-af5f-f5f1c7d6c55911
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYaaf42367-153e-4525-af5f-f5f1c7d6c55911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1595-05009015950020 TABLET, FILM COATED in 1 BOTTLE (50090-1595-0) 2015-01-050000-00-00NoNoCurrent
50090-1595-15009015950114 TABLET, FILM COATED in 1 BOTTLE (50090-1595-1) 2020-03-120000-00-00NoNoCurrent
50090-1595-25009015950230 TABLET, FILM COATED in 1 BOTTLE (50090-1595-2) 2015-01-050000-00-00NoNoCurrent