Ampicillin

Product NDC
83270-315
11-digit product format
832700315
Labeler code
83270
Product ID
83270-315_519f2785-e1bf-14fb-e063-6294a90ad704
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
ONESOURCE SPECIALTY PHARMA LIMITED
Application
ANDA202198
Marketing category
ANDA
Marketing start
2026-02-27
Substance
AMPICILLIN SODIUM
Active strength
10 g/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202198-001AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202198-001AP

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 UTC2026-02A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-073f01610625f2…
2019-09-15 20:21 UTC2019-09A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202198-001AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2014-04-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202198-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202198-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202198-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202198-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202198-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202198-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202198-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202198-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202198-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202198-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202198-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202198-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202198-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202198-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202198-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202198-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202198-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202198-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202198-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202198-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202198-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A202198-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202198-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202198-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202198-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A202198-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202198-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202198-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202198-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202198-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202198-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202198-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202198-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202198-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202198-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202198-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202198-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202198-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202198-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202198-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Ampicillin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN SODIUM10 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JFN36L5S8KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
789980Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
519f3ba6-606f-bfc4-e063-6294a90af884Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6Product name120250722
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3Product name220160201
c9385d77-2af7-47a4-bc97-1127e71caf9bProduct name320160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815Product name520151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85Product name320151026
8c59be9b-72b0-49e8-b7ef-1a80c10599deProduct name320150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83270-315-01Ampicillin1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmpicillinAMPICILLINONESOURCE SPECIALTY PHARMA LIMITED519f3ba6-606f-bfc4-e063-6294a90af8842026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202198
application number: ANDA202198
ndc (product): 83270-315
AmpicillinAMPICILLINArmas Pharmaceuticals Inc.65d94837-ca25-4728-932b-139d3bf4c7162025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202198
application number: ANDA202198

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
789980ampicillin 100 MG/ML Injectable SolutionPSN519f3ba6-606f-bfc4-e063-6294a90af8841
789980ampicillin 100 MG/ML Injectable SolutionSCD519f3ba6-606f-bfc4-e063-6294a90af8841
789980ampicillin (as ampicillin sodium) 100 MG/ML Injectable SolutionSY519f3ba6-606f-bfc4-e063-6294a90af8841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83270-315-01832700315011 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (83270-315-01) 2026-02-27NoNoCurrent