FDA.reportPublic FDA data

TRANEXAMIC ACID IN SODIUM CHLORIDE

Product NDC
80830-2329
11-digit product format
808302329
Labeler code
80830
Product ID
80830-2329_0793fd3b-1fa1-4ef3-ae2f-756ef19ecc56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tranexamic acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals Private Limited
Application
ANDA217155
Marketing category
ANDA
Marketing start
2023-10-23
Substance
TRANEXAMIC ACID
Active strength
10 mg/mL
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217155-001TRANEXAMIC ACIDTRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217155-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-168072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16a72a2bbeb626…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217155-001TRANEXAMIC ACID1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-10-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217155-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217155-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217155-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217155-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217155-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217155-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217155-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217155-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217155-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217155-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217155-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217155-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217155-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217155-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217155-001AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217155-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217155-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217155-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217155-001AP1a72a2bbeb626…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217155-001AP1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217155-001CGT2024-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217155-001CGT2024-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217155-001CGT2024-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217155-001CGT2024-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217155-001CGT2024-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217155-001CGT2024-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217155-001CGT2024-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217155-001CGT2024-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217155-001CGT2024-04-168072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217155-001CGT2024-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217155-001CGT2024-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217155-001CGT2024-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217155-001CGT2024-04-16a72a2bbeb626…

Additional Listing Data#

Finished product
Yes
Brand name base
TRANEXAMIC ACID IN SODIUM CHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANEXAMIC ACID10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6T84R30KC1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2170286Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1a38ece-2050-42ea-b9de-cae3e416c59dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80830-2329-2TRANEXAMIC ACID IN SODIUM CHLORIDE10 in 1 CARTONINJECTION, SOLUTION108
80830-2329-2TRANEXAMIC ACID IN SODIUM CHLORIDE1 in 1 POUCHINJECTION, SOLUTION18
80830-2329-3TRANEXAMIC ACID IN SODIUM CHLORIDE1 in 1 POUCHINJECTION, SOLUTION18
80830-2329-3TRANEXAMIC ACID IN SODIUM CHLORIDE12 in 1 CARTONINJECTION, SOLUTION128
80830-2329-4TRANEXAMIC ACID IN SODIUM CHLORIDE10 in 1 CARTONINJECTION, SOLUTION101
80830-2329-5TRANEXAMIC ACID IN SODIUM CHLORIDE1 in 1 POUCHINJECTION, SOLUTION11
80830-2329-5TRANEXAMIC ACID IN SODIUM CHLORIDE100 mL in 1 BAGINJECTION, SOLUTION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80830-2329-3ML - Milliliter80830-232949c0b871-cc52-4893-975b-c627e3144fb412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80830-2329TRANEXAMIC ACID IN SODIUM CHLORIDE (TRANEXAMIC ACID) INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED]8Current NDC, 4 package rows20250522_c1a38ece-2050-42ea-b9de-cae3e416c59d.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRANEXAMIC ACID IN SODIUM CHLORIDETRANEXAMIC ACIDAmneal Pharmaceuticals Private Limited615a9bec-f769-4774-8b05-22473b93668c2025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217155
application number: ANDA217155
ndc (product): 80830-2329
TRANEXAMIC ACID IN SODIUM CHLORIDETRANEXAMIC ACIDAmneal Pharmaceuticals Private Limitedc1a38ece-2050-42ea-b9de-cae3e416c59d2023-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217155
application number: ANDA217155
ndc (product): 80830-2329

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2170286tranexamic acid 1000 MG in 100 ML InjectionPSNc1a38ece-2050-42ea-b9de-cae3e416c59d8
2170286100 ML tranexamic acid 10 MG/ML InjectionSCDc1a38ece-2050-42ea-b9de-cae3e416c59d8
2170286tranexamic acid 1000 MG in 100 ML InjectionSYc1a38ece-2050-42ea-b9de-cae3e416c59d8
2170286tranexamic acid 1000 MG in 100 ML InjectionPSN615a9bec-f769-4774-8b05-22473b93668c1
2170286100 ML tranexamic acid 10 MG/ML InjectionSCD615a9bec-f769-4774-8b05-22473b93668c1
2170286tranexamic acid 1000 MG in 100 ML InjectionSY615a9bec-f769-4774-8b05-22473b93668c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80830-2329-28083023290210 POUCH in 1 CARTON (80830-2329-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAG10 pouch2023-10-23NoNoCurrent
80830-2329-38083023290312 POUCH in 1 CARTON (80830-2329-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG12 pouch2024-01-08NoNoCurrent
80830-2329-48083023290410 POUCH in 1 CARTON (80830-2329-4) / 1 BAG in 1 POUCH (80830-2329-5) / 100 mL in 1 BAG10 pouch2025-07-09NoNoCurrent
80830-2329-5808302329051 in 1 POUCHHistorical