Home NDC 63323-184 Folic Acid
Product NDC 63323-184
11-digit product format 633230184
Labeler code 63323
Product ID 63323-184_2445290b-6803-4364-ab42-65e6c550fdcd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Folic Acid
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA089202
Marketing category ANDA
Marketing start 2000-09-05
Substance FOLIC ACID
Active strength 5 mg/mL
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 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 A089202-001 FOLIC ACID FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089202-001 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.
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 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION RS 1986-02-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION RS 1986-02-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089202-001 FOLIC ACID 5MG/ML INJECTABLE / INJECTION AP RS 1986-02-18 e64feba35796…
Observed Orange Book normalized TE history# 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 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 63323-184-10 Folic Acid 1 in 1 CARTON INJECTION, SOLUTION 1 4 63323-184-10 Folic Acid 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FOLIC ACID ACTIVE INGREDIENT 935E97BOY8 FOLIC ACID INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 FOLIC ACID ACTIVE MOIETY 935E97BOY8 FOLIC ACID INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH FOLIC ACID INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU FOLIC ACID INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB FOLIC ACID INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FOLIC ACID INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-184 FOLIC ACID (FOLIC ACID) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241019_e215318c-4f8b-4711-ae76-f370d1da0f3b.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 63323-184-10 63323018410 1 VIAL, MULTI-DOSE in 1 CARTON (63323-184-10) / 10 mL in 1 VIAL, MULTI-DOSE 2000-09-05 0000-00-00 No No Current