Amoxicillin

Product NDC
0093-3109
11-digit product format
000933109
Labeler code
0093
Product ID
0093-3109_31223839-1653-4906-826a-f9d6af179334
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA061926
Marketing category
ANDA
Marketing start
1990-09-30
Substance
AMOXICILLIN
Active strength
500 mg/1
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 42.

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
A061926-001AMOXICILLINAMOXICILLIN250MGCAPSULE / ORALABApproved before 1982
A061926-003AMOXICILLINAMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A061926-001AB
A061926-003AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A061926-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A061926-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A061926-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061926-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A061926-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061926-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061926-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A061926-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061926-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A061926-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061926-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061926-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061926-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061926-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061926-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A061926-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061926-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A061926-003AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 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 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
239191Internal RxNorm lookup
308177Internal RxNorm lookup
308182Internal RxNorm lookup
308189Internal RxNorm lookup
308191Internal RxNorm lookup
308192Internal RxNorm lookup
308194Internal RxNorm lookup
313850Internal RxNorm lookup
598025Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c0f348a-a65d-409c-8668-207c82a5e3cbAvailable 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-3109-05Amoxicillin500 in 1 BOTTLECAPSULE50037
0093-3109-53Amoxicillin50 in 1 BOTTLECAPSULE5037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3109-01EA - Each0093-31099fa97d67-0d71-478f-94c3-cf71f2405b8a12024-01-04
0093-3109-05EA - Each0093-31093515fef5-d6f8-4ce3-812d-bded408c992212012-07-24
0093-3109-06EA - Each0093-3109e961aa0d-8d7d-4229-bf57-9d4d4be17f8c12024-01-04
0093-3109-19EA - Each0093-3109ba972ab7-a292-4f03-af52-d72ec365bc0c12012-07-24
0093-3109-53EA - Each0093-3109a6802d40-dea4-4e29-9e74-c59e27eb9c2912012-07-24
0093-3109-93EA - Each0093-31097ea0a40a-9b5e-4fbf-a471-bdfd61854b6312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [MEDVANTX, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN CAPSULE [MEDVANTX, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [MEDVANTX, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [MEDVANTX, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE [MEDVANTX, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3109AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE AMOXICILLIN CAPSULE [TEVA PHARMACEUTICALS USA, INC.]34Current NDC, Legacy NDC, 2 package rows20250502_4c0f348a-a65d-409c-8668-207c82a5e3cb.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINChartwell Governmental & Specialty RX, LLC809393b7-6271-4715-ae84-13fd8f9017722026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AMOXICILLINAMOXICILLINChartwell RX, LLCb07b5ac4-253e-4c83-91c3-3fdc46e91a0f2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AmoxicillinAMOXICILLINQPharma, Inc60c788d1-6c91-4456-848a-893e649e90be2026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AmoxicillinAMOXICILLINRedpharm Drug3d0025b4-b7bb-69db-e063-6294a90a0e702025-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.80a04b8a-110e-0aea-e053-2a91aa0ad0572025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8c3ba9cf-9a28-3965-e053-2a95a90a38ce2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AmoxicillinAMOXICILLINTeva Pharmaceuticals USA, Inc.4c0f348a-a65d-409c-8668-207c82a5e3cb2024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
ndc (product): 0093-3109
AmoxicillinAMOXICILLINAsclemed USA, Inc.be1d1a44-7ef3-445d-9970-494921de4c9d2023-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308177amoxicillin 125 MG Chewable TabletPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
598025amoxicillin 250 MG Chewable TabletPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308182amoxicillin 250 MG Oral CapsulePSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308191amoxicillin 500 MG Oral CapsulePSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308192amoxicillin 500 MG Oral TabletPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308194amoxicillin 875 MG Oral TabletPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308177amoxicillin 125 MG Chewable TabletSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
598025amoxicillin 250 MG Chewable TabletSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
308182amoxicillin 250 MG Oral CapsuleSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
313850amoxicillin 40 MG/ML Oral SuspensionSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
239191amoxicillin 50 MG/ML Oral SuspensionSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
308191amoxicillin 500 MG Oral CapsuleSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
308192amoxicillin 500 MG Oral TabletSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
308189amoxicillin 80 MG/ML Oral SuspensionSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
308194amoxicillin 875 MG Oral TabletSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
308191amoxicillin 500 MG Oral CapsulePSN60c788d1-6c91-4456-848a-893e649e90be11
308191amoxicillin 500 MG Oral CapsuleSCD60c788d1-6c91-4456-848a-893e649e90be11
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY60c788d1-6c91-4456-848a-893e649e90be11
308191amoxicillin 500 MG Oral CapsulePSNea2481a1-cab6-4c2e-a333-3d687367895d4
308191amoxicillin 500 MG Oral CapsuleSCDea2481a1-cab6-4c2e-a333-3d687367895d4
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYea2481a1-cab6-4c2e-a333-3d687367895d4
308191amoxicillin 500 MG Oral CapsulePSNfadc4d59-d937-4f22-be6b-ce92fbb004822
308191amoxicillin 500 MG Oral CapsuleSCDfadc4d59-d937-4f22-be6b-ce92fbb004822
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYfadc4d59-d937-4f22-be6b-ce92fbb004822
308191amoxicillin 500 MG Oral CapsulePSNbe1d1a44-7ef3-445d-9970-494921de4c9d1
308191amoxicillin 500 MG Oral CapsulePSN3bf1718a-fedc-4834-831e-b3b044f80ee61
308191amoxicillin 500 MG Oral CapsuleSCDbe1d1a44-7ef3-445d-9970-494921de4c9d1
308191amoxicillin 500 MG Oral CapsuleSCD3bf1718a-fedc-4834-831e-b3b044f80ee61
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYbe1d1a44-7ef3-445d-9970-494921de4c9d1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY3bf1718a-fedc-4834-831e-b3b044f80ee61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3109-0500093310905500 CAPSULE in 1 BOTTLE (0093-3109-05) 500 capsule1990-09-300000-00-00NoNoCurrent
0093-3109-530009331095350 CAPSULE in 1 BOTTLE (0093-3109-53) 50 capsule1990-09-300000-00-00NoNoCurrent