Folic Acid

Product NDC: 70518-4459
Requested package NDC: 70518-4459-1
11-digit product format: 705184459
Labeler code: 70518
Product ID: 70518-4459_3dfb4076-22cf-1019-e063-6294a90a80c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Folic Acid
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA211064
Marketing category: ANDA
Marketing start: 2025-08-27
Substance: FOLIC ACID
Active strength: 1 mg/1
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211064-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA		2019-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211064-001	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 · 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	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211064-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2019-03-08	`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	A211064-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211064-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211064-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211064-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211064-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211064-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211064-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211064-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211064-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211064-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211064-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211064-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211064-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211064-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211064-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211064-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211064-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211064-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211064-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211064-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211064-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211064-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211064-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211064-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211064-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211064-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211064-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211064-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211064-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211064-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211064-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211064-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211064-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211064-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211064-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211064-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211064-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211064-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211064-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211064-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Folic Acid
Listing expiration: 2026-12-31

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
bda4687e-929a-434d-ab59-909cf2ed73a2	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
70518-4459-0	Folic Acid	30 in 1 BLISTER PACK	TABLET	30		2
70518-4459-1	Folic Acid	7 in 1 BLISTER PACK	TABLET	7		2

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Folic Acid	FOLIC ACID	Rising Pharma Holdings, Inc.	0baa10dd-6d1d-4946-8236-566451132da3	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	a1b71c5d-c842-43fd-9557-2bb4e934b914	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Preferred Pharmaceuticals Inc.	b4c3a754-64cd-499a-a32f-a6e935c41355	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	40ab3c91-5a5b-fa1d-e063-6394a90a7454	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	4889d474-bd72-46ba-81d6-5511d8a85abb	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	41914ac8-f4f5-4d70-b9f2-9f88c59d67a6	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	1383dce2-0b81-4694-a662-27576f867eae	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Method Pharmaceuticals, LLC	b9c315ff-cecb-8b75-e053-2995a90aa204	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	REMEDYREPACK INC.	bda4687e-929a-434d-ab59-909cf2ed73a2	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064 ndc (package): 70518-4459-1 ndc (product): 70518-4459 ndc11 (package): 70518445901
Folic Acid	FOLIC ACID	NuCare Pharmaceuticals,Inc.	fa43f66c-9ae4-cd36-e053-6394a90a1526	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	fd0ec9f8-f547-4e5a-9847-a7ddfc3344bc	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Bryant Ranch Prepack	1b050122-73e9-48c7-9b26-431eaadddcfe	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	A-S Medication Solutions	16f8a1a1-ee81-4cd3-85e7-e1eae83fad67	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	A-S Medication Solutions	b48f4a4e-ece7-4bbb-b659-ed446cd9f0c9	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Proficient Rx LP	32203472-8724-4ba7-b0be-d834c3d7f074	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064
Folic Acid	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	f8ffce0d-2b94-4a14-a08e-97646436cf6d	2023-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211064 application number: ANDA211064

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	bda4687e-929a-434d-ab59-909cf2ed73a2	2
310410	folic acid 1 MG Oral Tablet	SCD	bda4687e-929a-434d-ab59-909cf2ed73a2	2
310410	folate 1 MG Oral Tablet	SY	bda4687e-929a-434d-ab59-909cf2ed73a2	2
310410	vitamin B9 1,000 MCG Oral Tablet	SY	bda4687e-929a-434d-ab59-909cf2ed73a2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4459-1	70518445901	7 TABLET in 1 BLISTER PACK (70518-4459-1)	7 tablet	2025-09-04	No	No	Current