Leucovorin Calcium

Product NDC: 0555-0485
Requested package NDC: 0555-0485-99
11-digit product format: 005550485
Labeler code: 0555
Product ID: 0555-0485_3ba61b64-dd4e-44d7-8348-85a193c7c267
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Leucovorin Calcium
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA071199
Marketing category: ANDA
Marketing start: 1990-06-30
Substance: LEUCOVORIN CALCIUM
Active strength: 25 mg/1
Pharmacologic classes: Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	0555-0485	0555-0485-99	UNFINISHED	Active or certified unfinished drug listing		2026-08-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071199-001	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		1987-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071199-001	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071199-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071199-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071199-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071199-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071199-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071199-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071199-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071199-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071199-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071199-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071199-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071199-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071199-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071199-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071199-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071199-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071199-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071199-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071199-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071199-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071199-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071199-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071199-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071199-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071199-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071199-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071199-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071199-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071199-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071199-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071199-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071199-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071199-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071199-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071199-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071199-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071199-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071199-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071199-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071199-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Leucovorin Calcium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEUCOVORIN CALCIUM	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RPR1R4C0P4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197862	Internal RxNorm lookup
197863	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
94669fc8-3c1c-4228-be27-09a1cd468c36	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
31adef49-84cb-4c51-b122-69e924e10ea3	Product name	4	20240827
df40773e-fe5a-474c-8d32-d19c7094e396	Product name	2	20240813
cd1aa5b9-18a7-4dc4-8a13-b5c677c859a2	Product name	1	20231116
38866763-6a8e-4096-95c3-082a000c243d	Product name	1	20230809
7ce39568-aceb-b33a-23ed-c4964cdcf486	Product name	2	20210211
6c712ad1-eecf-448f-84d9-5c0c307a7112	Product name	1	20161130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0555-0485-27	Leucovorin Calcium	25 in 1 BOTTLE	TABLET	25		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-0485-27	EA - Each	0555-0485	1d78c335-47d7-4535-a925-39d46e0cee4d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEUCOVORIN CALCIUM	ACTIVE INGREDIENT	RPR1R4C0P4	LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]	5
LEUCOVORIN	ACTIVE MOIETY	Q573I9DVLP	LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEUCOVORIN CALCIUM TABLET [BARR LABORATORIES INC.]	5
LEUCOVORIN CALCIUM	ACTIVE INGREDIENT	RPR1R4C0P4	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
LEUCOVORIN	ACTIVE MOIETY	Q573I9DVLP	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEUCOVORIN CALCIUM TABLET [MYLAN INSTITUTIONAL INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0555-0485	LEUCOVORIN CALCIUM TABLET [TEVA PHARMACEUTICALS USA, INC.]	15	Current NDC, Legacy NDC, 1 package rows	20241204_94669fc8-3c1c-4228-be27-09a1cd468c36.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leucovorin Calcium	LEUCOVORIN CALCIUM	American Health Packaging	f7004cbd-9827-466e-9683-adce4f13c6a6	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071199 application number: ANDA071199
Leucovorin Calcium	LEUCOVORIN CALCIUM	Teva Pharmaceuticals USA, Inc.	94669fc8-3c1c-4228-be27-09a1cd468c36	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071199 application number: ANDA071199 ndc (product): 0555-0485

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RPR1R4C0P4	LEUCOVORIN CALCIUM	1492-18-8	LEUCOVORIN CALCIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197862	leucovorin calcium 25 MG Oral Tablet	PSN	94669fc8-3c1c-4228-be27-09a1cd468c36	18
197863	leucovorin calcium 5 MG Oral Tablet	PSN	94669fc8-3c1c-4228-be27-09a1cd468c36	18
197862	leucovorin 25 MG Oral Tablet	SCD	94669fc8-3c1c-4228-be27-09a1cd468c36	18
197863	leucovorin 5 MG Oral Tablet	SCD	94669fc8-3c1c-4228-be27-09a1cd468c36	18
197862	leucovorin 25 MG (as leucovorin calcium 27.01 MG) Oral Tablet	SY	94669fc8-3c1c-4228-be27-09a1cd468c36	18
197863	leucovorin 5 MG (as leucovorin calcium 5.4 MG) Oral Tablet	SY	94669fc8-3c1c-4228-be27-09a1cd468c36	18
197862	leucovorin calcium 25 MG Oral Tablet	PSN	f7004cbd-9827-466e-9683-adce4f13c6a6	8
197862	leucovorin 25 MG Oral Tablet	SCD	f7004cbd-9827-466e-9683-adce4f13c6a6	8
197862	leucovorin 25 MG (as leucovorin calcium 27.01 MG) Oral Tablet	SY	f7004cbd-9827-466e-9683-adce4f13c6a6	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
0555-0485-99	00555048599	50000 TABLET in 1 CONTAINER (0555-0485-99)	50000 tablet	10-JUN-21	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leucovorin Calcium Tablets USP Rx Only 8422794/0725F	American Health Packaging	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	9
Leucovorin Calcium	Teva Pharmaceuticals USA, Inc.	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	18
Leucovorin Calcium Tablets USP	Mylan institutional Inc.	2022-12-28	HUMAN PRESCRIPTION DRUG LABEL	9