LEVOLEUCOVORIN CALCIUM

Product NDC
14335-341
11-digit product format
143350341
Labeler code
14335
Product ID
14335-341_fcf83646-5cb1-2844-e053-6294a90a8a92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levoleucovorin injection
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA217314
Marketing category
ANDA
Marketing start
2023-05-31
Substance
LEVOLEUCOVORIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
Folate Analog [EPC], Folic Acid [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
A217314-001LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22
A217314-002LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217314-001AP
A217314-002AP

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-228072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-226a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-221c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-229b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217314-001LEVOLEUCOVORIN CALCIUMEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217314-002LEVOLEUCOVORIN CALCIUMEQ 250MG BASE/25ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-05-22a67488948f0b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217314-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217314-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217314-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217314-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217314-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217314-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217314-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217314-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217314-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217314-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217314-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217314-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217314-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217314-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217314-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217314-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217314-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217314-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217314-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217314-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217314-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217314-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217314-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217314-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217314-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217314-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217314-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217314-002AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217314-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217314-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217314-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217314-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217314-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217314-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217314-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217314-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217314-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217314-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217314-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217314-002AP1a67488948f0b…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOLEUCOVORIN CALCIUM10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
778XL6VBS8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1720765Internal RxNorm lookup
1720773Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c10b0c18-dd7c-4a76-a79b-b8d38a08ab87Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5f7850a-bc65-4866-8340-2b197ae4d8caProduct name920200206
2642c4da-5f9c-4531-8406-dc7d1c3a9032Product name120190201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14335-341-01LEVOLEUCOVORIN CALCIUM1 in 1 CARTONINJECTION, SOLUTION11
14335-341-01LEVOLEUCOVORIN CALCIUM25 in 1 VIALINJECTION, SOLUTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-341LEVOLEUCOVORIN CALCIUM (LEVOLEUCOVORIN INJECTION) INJECTION, SOLUTION [HAINAN POLY PHARM. CO., LTD.]1Current NDC, 2 package rows20230601_c10b0c18-dd7c-4a76-a79b-b8d38a08ab87.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
LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN INJECTIONSlate Run Pharmaceuticals124bc214-62f8-40f9-a227-a35e2d1ff2a02023-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217314
application number: ANDA217314
LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN INJECTIONHainan Poly Pharm. Co., Ltd.c10b0c18-dd7c-4a76-a79b-b8d38a08ab872023-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217314
application number: ANDA217314
ndc (product): 14335-341

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1720765LEVOleucovorin 175 MG in 17.5 mL InjectionPSNc10b0c18-dd7c-4a76-a79b-b8d38a08ab871
1720773LEVOleucovorin 250 MG in 25 ML InjectionPSNc10b0c18-dd7c-4a76-a79b-b8d38a08ab871
172076517.5 ML levoleucovorin 10 MG/ML InjectionSCDc10b0c18-dd7c-4a76-a79b-b8d38a08ab871
172077325 ML levoleucovorin 10 MG/ML InjectionSCDc10b0c18-dd7c-4a76-a79b-b8d38a08ab871
1720765levoleucovorin (as levoleucovorin calcium) 175 MG per 17.5 mL InjectionSYc10b0c18-dd7c-4a76-a79b-b8d38a08ab871
1720773levoleucovorin (as levoleucovorin calcium) 250 MG per 25 ML InjectionSYc10b0c18-dd7c-4a76-a79b-b8d38a08ab871
1720765levoleucovorin 175 MG per 17.5 mL InjectionSYc10b0c18-dd7c-4a76-a79b-b8d38a08ab871
1720773levoleucovorin 250 MG per 25 ML InjectionSYc10b0c18-dd7c-4a76-a79b-b8d38a08ab871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14335-341-01143350341011 VIAL in 1 CARTON (14335-341-01) / 25 INJECTION, SOLUTION in 1 VIAL1 vial2023-05-31NoNoCurrent