Folic Acid

Product NDC: 67544-989
Requested package NDC: 67544-989-65
11-digit product format: 675440989
Labeler code: 67544
Product ID: 67544-989_583ccb68-3d4b-4b3b-b0fa-c84dd33a0753
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Folic Acid
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA204418
Marketing category: ANDA
Marketing start: 2016-02-01
Marketing end: 0000-00-00
Substance: FOLIC ACID
Active strength: 1 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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
excluded package	package	67544-989	67544-989-65	D	Discontinued by firm		2026-08-11

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
A204418-001	FOLIC ACID	FOLIC ACID	1MG	TABLET / ORAL	AA		2015-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204418-001	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	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`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	A204418-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204418-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204418-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204418-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204418-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204418-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204418-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204418-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204418-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204418-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204418-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204418-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204418-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204418-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204418-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204418-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204418-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204418-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204418-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204418-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204418-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204418-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204418-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204418-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204418-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204418-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204418-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204418-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204418-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204418-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204418-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204418-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204418-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204418-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204418-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204418-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204418-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204418-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204418-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204418-001	AA	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-989-30	EA - Each	67544-989	bb388b1e-0d2d-41a3-8469-08495a50eb17	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-989	FOLIC ACID TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC	20171128_b4493a96-34b8-4124-9b1e-a41e71bc8950.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	Coupler LLC	544e394d-3555-8ab1-e063-6394a90ade00	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	93580111-3e70-4a87-8834-c7aa99ec75e3	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	PD-Rx Pharmaceuticals, Inc.	726bb436-69e3-452f-9f28-153b58bf3ca5	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	Bryant Ranch Prepack	0e7cb7ea-c94e-4ce6-8149-311dc9c94e03	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
Folic Acid	FOLIC ACID	DIRECT RX	bfcb0849-6d9b-7705-e053-2a95a90a6541	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	SUNRISE PHARMACEUTICAL, INC.	6854412b-7ecb-4107-85eb-730f14e23f06	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	A-S Medication Solutions	21f7ccf1-1de6-4a6e-b017-2b85c9d62d13	2023-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	A-S Medication Solutions	a9583b76-822d-486a-947a-2be6356637d0	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418
FOLIC ACID	FOLIC ACID	Aphena Pharma Solutions - Tennessee, LLC	dc4d097d-6e7e-4229-9853-04c31444d703	2022-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204418 application number: ANDA204418

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67544-989-65	67544098965	100 TABLET in 1 BOTTLE, PLASTIC (67544-989-65)	100 tablet	2017-03-20	0000-00-00	No	No	Current