Folic Acid

Product NDC: 0904-7224
11-digit product format: 009047224
Labeler code: 0904
Product ID: 0904-7224_e902fb04-d6a7-4a77-826d-db721d67647e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Folic Acid
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA040625
Marketing category: ANDA
Marketing start: 2022-03-07
Substance: FOLIC ACID
Active strength: 1 mg/1
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 42.

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
A040625-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040625-001	AA

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040625-001	FOLIC ACID	1MG	TABLET / ORAL	AA	RS	2005-07-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040625-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040625-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040625-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040625-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040625-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040625-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040625-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040625-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040625-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040625-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040625-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040625-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040625-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040625-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040625-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040625-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040625-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040625-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040625-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040625-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040625-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040625-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040625-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040625-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040625-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040625-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040625-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040625-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040625-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040625-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040625-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040625-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040625-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040625-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040625-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040625-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040625-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040625-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040625-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040625-001	AA	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Folic Acid
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOLIC ACID	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
935E97BOY8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310410	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
7778ac96-7817-455a-a177-22ecb276c67f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-7224-61	Folic Acid	1 in 1 BLISTER PACK	TABLET	1		4
0904-7224-61	Folic Acid	100 in 1 CARTON	TABLET	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7224-61	EA - Each	0904-7224	40604006-014a-4b9d-9708-639134098305	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7224	FOLIC ACID TABLET [MAJOR PHARMACEUTICALS]	2	Current NDC, Legacy NDC, 2 package rows	20241020_7778ac96-7817-455a-a177-22ecb276c67f.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Folic Acid	FOLIC ACID	Northwind Health Company, LLC	03b0aee4-804a-de63-e063-6394a90a6635	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	Major Pharmaceuticals	7778ac96-7817-455a-a177-22ecb276c67f	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625 ndc (product): 0904-7224
Folic Acid	FOLIC ACID	Cardinal Health 107, LLC	624469a1-ded9-453a-973e-c5a2f0602bb0	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	Cardinal Health 107, LLC	6dd867fe-597e-4915-8baf-98a605bf9324	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	Amneal Pharmaceuticals of New York LLC	fd85395e-6a0b-4072-a80b-36095c0c6dd6	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	American Health Packaging	fc6dc1e1-f63e-4239-a1eb-67525569f68c	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	NuCare Pharmaceuticals,Inc.	065e403b-7ba8-b584-e063-6294a90a15ec	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	Amneal Pharmaceuticals LLC	c8fe09f0-b32b-43e3-8de7-ed38593b33b4	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625
Folic Acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	d6c7ac9b-f44a-4f10-9d1d-efbebd37c313	2019-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040625 application number: ANDA040625

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
935E97BOY8	FOLIC ACID	59-30-3	FOLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310410	folic acid 1 MG Oral Tablet	PSN	624469a1-ded9-453a-973e-c5a2f0602bb0	5
310410	folic acid 1 MG Oral Tablet	SCD	624469a1-ded9-453a-973e-c5a2f0602bb0	5
310410	folate 1 MG Oral Tablet	SY	624469a1-ded9-453a-973e-c5a2f0602bb0	5
310410	vitamin B9 1,000 MCG Oral Tablet	SY	624469a1-ded9-453a-973e-c5a2f0602bb0	5
310410	folic acid 1 MG Oral Tablet	PSN	7778ac96-7817-455a-a177-22ecb276c67f	4
310410	folic acid 1 MG Oral Tablet	SCD	7778ac96-7817-455a-a177-22ecb276c67f	4
310410	folate 1 MG Oral Tablet	SY	7778ac96-7817-455a-a177-22ecb276c67f	4
310410	vitamin B9 1,000 MCG Oral Tablet	SY	7778ac96-7817-455a-a177-22ecb276c67f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7224-61	00904722461	100 BLISTER PACK in 1 CARTON (0904-7224-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2022-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Folic Acid Tablets, USP (1 mg) Rx only	Major Pharmaceuticals	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	5
Folic Acid Tablets, USP (1 mg) Rx only	Cardinal Health 107, LLC	2026-05-15	HUMAN PRESCRIPTION DRUG LABEL	5