Home NDC 67157-101 Ascor
Product NDC 67157-101
11-digit product format 671570101
Labeler code 67157
Product ID 67157-101_43fa2622-9526-16d2-e063-6394a90a7c84
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ascorbic Acid
Dosage form INJECTION
Route INTRAVENOUS
Labeler McGuff Pharmaceuticals, Inc.
Application NDA209112
Marketing category NDA
Marketing start 2018-01-15
Substance ASCORBIC ACID
Active strength 500 mg/mL
Pharmacologic classes Ascorbic Acid [CS], Vitamin C [EPC]
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 N209112-001 ASCOR ASCORBIC ACID 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N209112-001 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 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 N209112-001 AP 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209112-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209112-001 AP 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209112-001 AP 1 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Ascor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASCORBIC ACID 500 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PQ6CK8PD0R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308395 Internal RxNorm lookup 2002739 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 67157-101-50 Ascor 1 in 1 CARTON INJECTION 1 17 67157-101-50 Ascor 50 mL in 1 VIAL, GLASS INJECTION 50 17 67157-101-51 Ascor 50 mL in 1 VIAL, GLASS INJECTION 50 17 67157-101-51 Ascor 25 in 1 TRAY INJECTION 25 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67157-101 ASCOR (ASCORBIC ACID) INJECTION [MCGUFF PHARMACEUTICALS, INC.] 16 Current NDC, Legacy NDC, 4 package rows 20241207_388aad52-fc01-4784-9791-1dbc80c69306.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ascor ASCORBIC ACID McGuff Pharmaceuticals, Inc. 388aad52-fc01-4784-9791-1dbc80c69306 2026-05-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 209112 application number: NDA209112 ndc (product): 67157-101
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 67157-101-50 67157010150 1 VIAL, GLASS in 1 CARTON (67157-101-50) / 50 mL in 1 VIAL, GLASS 2018-01-15 0000-00-00 No No Current 67157-101-51 67157010151 25 VIAL, GLASS in 1 TRAY (67157-101-51) / 50 mL in 1 VIAL, GLASS 2018-01-15 0000-00-00 No No Current