Folic Acid

Product NDC: 10135-182
Requested package NDC: 10135-182-01
11-digit product format: 101350182
Labeler code: 10135
Product ID: 10135-182_ba726c8a-bfad-11f7-e053-2995a90a239e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Folic Acid
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
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: 2022-12-31
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	10135-182	10135-182-01	I	Inactivated by FDA		2026-08-17

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 · 15 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 42 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
2026-08-18 06:07:40	2026-07	A204418-001	FOLIC ACID	1MG	TABLET / ORAL	AA	2015-07-28	`caaa826d4ba7…`
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…`

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	A204418-001	AA	1	`caaa826d4ba7…`
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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
10135-182-01	2023-01-30	Folic Acid
10135-182-10	2023-01-30	Folic Acid
10135-182-01	2021-02-04	Folic Acid
10135-182-10	2021-02-04	Folic Acid
10135-182-01	2021-01-29	Folic Acid
10135-182-10	2021-01-29	Folic Acid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-182-01	Folic Acid	100 in 1 BOTTLE, PLASTIC	TABLET	100		4
10135-182-10	Folic Acid	1000 in 1 BOTTLE	TABLET	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-182-01	EA - Each	10135-182	84ae0fdd-007e-482a-95c8-a39b6c188569	1	2016-03-04
10135-182-10	EA - Each	10135-182	b6779f62-8b24-4407-a8bb-dbbf57a0344f	1	2016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-182	FOLIC ACID TABLET [MARLEX PHARMACEUTICALS INC]	4	Legacy NDC, 2 package rows	20210205_35cd5498-0af8-4bcc-a755-bf30f37b091a.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310410	folic acid 1 MG Oral Tablet	PSN	35cd5498-0af8-4bcc-a755-bf30f37b091a	4
310410	folic acid 1 MG Oral Tablet	SCD	35cd5498-0af8-4bcc-a755-bf30f37b091a	4
310410	folate 1 MG Oral Tablet	SY	35cd5498-0af8-4bcc-a755-bf30f37b091a	4
310410	vitamin B9 1,000 MCG Oral Tablet	SY	35cd5498-0af8-4bcc-a755-bf30f37b091a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-182-01	10135018201	100 TABLET in 1 BOTTLE, PLASTIC (10135-182-01)	100 tablet	2016-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Folic Acid	Marlex Pharmaceuticals Inc	2021-02-03	HUMAN PRESCRIPTION DRUG LABEL	4
Folic Acid	Aphena Pharma Solutions - Tennessee, LLC	2017-11-27	HUMAN PRESCRIPTION DRUG LABEL	2