Amoxicillin

Product NDC
65862-071
11-digit product format
658620071
Labeler code
65862
Product ID
65862-071_3e3ca279-1838-4348-a01c-df10a8bcb8b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065334
Marketing category
ANDA
Marketing start
2006-12-28
Substance
AMOXICILLIN
Active strength
400 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A065334-001AMOXICILLINAMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28
A065334-002AMOXICILLINAMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065334-001AB
A065334-002AB

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 UTC2026-02A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28782e0a99824c…

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 UTC2026-02A065334-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065334-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065334-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065334-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065334-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065334-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065334-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065334-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065334-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065334-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065334-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065334-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065334-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065334-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065334-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065334-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065334-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065334-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN400 mg/5mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308189Internal RxNorm lookup
313850Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3cacd754-73f4-496e-a529-9ca39fa6692dAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-071-01Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10015
65862-071-50Amoxicillin50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5015
65862-071-75Amoxicillin75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-071-01ML - Milliliter65862-071dd061282-825a-45e6-bc14-eb2a306703c312012-07-24
65862-071-50ML - Milliliter65862-071cee83985-5d05-4b2a-a7f8-4db7b8048d0212012-07-24
65862-071-75ML - Milliliter65862-07176fdf240-5e70-479c-8180-639ab14b612c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC]4
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC]4
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC]4
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC]4
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]3
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]3
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-071AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 3 package rows20240612_3cacd754-73f4-496e-a529-9ca39fa6692d.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.573fcf4a-2b87-45d9-ac73-e1dec4fbc28b2026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINREMEDYREPACK INC.2732a8c7-9e4b-43c9-9712-df4b237ab69c2025-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AMOXICILLINAMOXICILLINDirectRxcedde8f5-aadd-53de-e053-2995a90aab162025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINRising Pharma Holdings, Inc.554239db-69fe-405a-910a-d9f9e3f8b6ed2024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.97a657a3-8238-f5f1-e053-2a95a90a7a7a2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINAurobindo Pharma Limited3cacd754-73f4-496e-a529-9ca39fa6692d2024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
ndc (product): 65862-071
AmoxicillinAMOXICILLINA-S Medication Solutionsd5ecb620-5267-4dcf-be81-64c7766516f52024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINA-S Medication Solutions3d8a700b-b23b-459a-a19a-213dd39b6a3a2024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINA-S Medication Solutions1dc5cc5a-59ba-4bc9-b581-cb7b70ce26522024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AMOXICILLINAMOXICILLINDIRECT RX0173e9de-a995-4386-bb65-8fc2bbf347f92024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINProficient Rx LPfcdaba34-373f-4d4e-8203-76f02e3bb00a2024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINProficient Rx LPd5eba477-e255-4d97-9e16-30543c2986802023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINProficient Rx LPe40f3e20-facf-46f4-89c7-3593bc27d0fc2021-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN3cacd754-73f4-496e-a529-9ca39fa6692d15
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN3cacd754-73f4-496e-a529-9ca39fa6692d15
313850amoxicillin 40 MG/ML Oral SuspensionSCD3cacd754-73f4-496e-a529-9ca39fa6692d15
308189amoxicillin 80 MG/ML Oral SuspensionSCD3cacd754-73f4-496e-a529-9ca39fa6692d15
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY3cacd754-73f4-496e-a529-9ca39fa6692d15
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY3cacd754-73f4-496e-a529-9ca39fa6692d15
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY3cacd754-73f4-496e-a529-9ca39fa6692d15
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNfcdaba34-373f-4d4e-8203-76f02e3bb00a7
308189amoxicillin 80 MG/ML Oral SuspensionSCDfcdaba34-373f-4d4e-8203-76f02e3bb00a7
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYfcdaba34-373f-4d4e-8203-76f02e3bb00a7
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN3d8a700b-b23b-459a-a19a-213dd39b6a3a6
308189amoxicillin 80 MG/ML Oral SuspensionSCD3d8a700b-b23b-459a-a19a-213dd39b6a3a6
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY3d8a700b-b23b-459a-a19a-213dd39b6a3a6
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN0173e9de-a995-4386-bb65-8fc2bbf347f95
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN0173e9de-a995-4386-bb65-8fc2bbf347f95
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD0173e9de-a995-4386-bb65-8fc2bbf347f95
308189amoxicillin 80 MG/ML Oral SuspensionSCD0173e9de-a995-4386-bb65-8fc2bbf347f95
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY0173e9de-a995-4386-bb65-8fc2bbf347f95
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY0173e9de-a995-4386-bb65-8fc2bbf347f95
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
313850amoxicillin 40 MG/ML Oral SuspensionSCD573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
308189amoxicillin 80 MG/ML Oral SuspensionSCD573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN97a657a3-8238-f5f1-e053-2a95a90a7a7a3
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNf27aa99b-2b77-48d6-8af4-3ae26c04d5b63
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNd5ecb620-5267-4dcf-be81-64c7766516f53
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN1dc5cc5a-59ba-4bc9-b581-cb7b70ce26523
308189amoxicillin 80 MG/ML Oral SuspensionSCD1dc5cc5a-59ba-4bc9-b581-cb7b70ce26523
308189amoxicillin 80 MG/ML Oral SuspensionSCDd5ecb620-5267-4dcf-be81-64c7766516f53
308189amoxicillin 80 MG/ML Oral SuspensionSCDf27aa99b-2b77-48d6-8af4-3ae26c04d5b63
308189amoxicillin 80 MG/ML Oral SuspensionSCD97a657a3-8238-f5f1-e053-2a95a90a7a7a3
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY1dc5cc5a-59ba-4bc9-b581-cb7b70ce26523
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYd5ecb620-5267-4dcf-be81-64c7766516f53
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYf27aa99b-2b77-48d6-8af4-3ae26c04d5b63
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY97a657a3-8238-f5f1-e053-2a95a90a7a7a3
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN4d15e38c-2025-4570-839f-dfd4febd6ce32
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN4d15e38c-2025-4570-839f-dfd4febd6ce32
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNafad71c6-5ecf-4137-ba61-2ef59b3b81ee2
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNd3c32596-2913-7a49-e053-2a95a90a00a02
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNc721aa04-44c9-4326-9647-8a012ecf30862
313850amoxicillin 40 MG/ML Oral SuspensionSCD4d15e38c-2025-4570-839f-dfd4febd6ce32
308189amoxicillin 80 MG/ML Oral SuspensionSCDafad71c6-5ecf-4137-ba61-2ef59b3b81ee2
308189amoxicillin 80 MG/ML Oral SuspensionSCDd3c32596-2913-7a49-e053-2a95a90a00a02
308189amoxicillin 80 MG/ML Oral SuspensionSCD4d15e38c-2025-4570-839f-dfd4febd6ce32
308189amoxicillin 80 MG/ML Oral SuspensionSCDc721aa04-44c9-4326-9647-8a012ecf30862
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY4d15e38c-2025-4570-839f-dfd4febd6ce32
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY4d15e38c-2025-4570-839f-dfd4febd6ce32
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYd3c32596-2913-7a49-e053-2a95a90a00a02
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYc721aa04-44c9-4326-9647-8a012ecf30862
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYafad71c6-5ecf-4137-ba61-2ef59b3b81ee2
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY4d15e38c-2025-4570-839f-dfd4febd6ce32
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN2732a8c7-9e4b-43c9-9712-df4b237ab69c1
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNc5774511-bee9-4ebb-a9aa-9e74de8d840e1
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN5509ede4-74d3-42af-a1dd-cee95de5d2e61
308189amoxicillin 80 MG/ML Oral SuspensionSCDc5774511-bee9-4ebb-a9aa-9e74de8d840e1
308189amoxicillin 80 MG/ML Oral SuspensionSCD2732a8c7-9e4b-43c9-9712-df4b237ab69c1
308189amoxicillin 80 MG/ML Oral SuspensionSCD5509ede4-74d3-42af-a1dd-cee95de5d2e61
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY5509ede4-74d3-42af-a1dd-cee95de5d2e61
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY2732a8c7-9e4b-43c9-9712-df4b237ab69c1
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYc5774511-bee9-4ebb-a9aa-9e74de8d840e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-071-0165862007101100 mL in 1 BOTTLE (65862-071-01) 100 ml2006-12-280000-00-00NoNoCurrent
65862-071-506586200715050 mL in 1 BOTTLE (65862-071-50) 50 ml2006-12-280000-00-00NoNoCurrent
65862-071-756586200717575 mL in 1 BOTTLE (65862-071-75) 75 ml2006-12-280000-00-00NoNoCurrent