Home NDC 25021-705 Acetaminophen
Product NDC 25021-705
11-digit product format 250210705
Labeler code 25021
Product ID 25021-705_eab98344-59bc-4da5-a30f-ab753c29f1f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA219215
Marketing category ANDA
Marketing start 2025-07-15
Substance ACETAMINOPHEN
Active strength 10 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 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219215-001 ACETAMINOPHEN ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-02 A219215-002 ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2025-04-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-10-15 13:18:30 2026-09 A219215-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219215-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2025-04-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219215-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219215-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2025-04-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219215-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219215-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2025-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219215-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219215-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2025-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219215-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219215-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2025-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219215-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219215-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2025-04-02 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219215-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219215-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2025-04-02 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483017 Internal RxNorm lookup 2480095 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25021-705-82 Acetaminophen 10 in 1 CARTON INJECTION, SOLUTION 10 1 25021-705-82 Acetaminophen 50 mL in 1 BAG INJECTION, SOLUTION 50 1 25021-705-87 Acetaminophen 100 mL in 1 BAG INJECTION, SOLUTION 100 1 25021-705-87 Acetaminophen 20 in 1 CARTON INJECTION, SOLUTION 20 1
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 25021-705-82 25021070582 10 BAG in 1 CARTON (25021-705-82) / 50 mL in 1 BAG 10 bag 2025-07-15 No No Current 25021-705-87 25021070587 20 BAG in 1 CARTON (25021-705-87) / 100 mL in 1 BAG 20 bag 2025-07-15 No No Current