Home NDC 39822-1100 Folic Acid
Product NDC 39822-1100
11-digit product format 398221100
Labeler code 39822
Product ID 39822-1100_48eb23cf-7425-a5cc-e063-6294a90a5021
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Folic Acid
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler XGen Pharmaceuticals DJB, Inc.
Application ANDA202522
Marketing category ANDA
Marketing start 2019-11-17
Substance FOLIC ACID
Active strength 5 mg/mL
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 A202522-001 FOLIC ACID FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202522-001 AP
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.
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 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202522-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP 2019-11-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 5 mg/mL
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 237786 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 39822-1100-1 Folic Acid 1 in 1 CARTON INJECTION, SOLUTION 1 5 39822-1100-1 Folic Acid 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39822-1100 FOLIC ACID INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20220223_c5b2b84d-9f5e-4b81-ba10-9f2854e5dce9.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 39822-1100-1 39822110001 1 VIAL, MULTI-DOSE in 1 CARTON (39822-1100-1) / 10 mL in 1 VIAL, MULTI-DOSE 2019-11-17 0000-00-00 No No Current