Home NDC 68083-647-01 Acetaminophen
Product NDC 68083-647
Requested package NDC 68083-647-01
11-digit product format 680830647
Labeler code 68083
Product ID 68083-647_04cdb516-3f83-45c4-a608-6a08b1fb6cf0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA219215
Marketing category ANDA
Marketing start 2025-04-02
Substance ACETAMINOPHEN
Active strength 10 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 43 .
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 2026-09-14 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 2026-12-31 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 68083-647-01 Acetaminophen 24 in 1 CARTON INJECTION, SOLUTION 24 4 68083-647-01 Acetaminophen 50 mL in 1 BAG INJECTION, SOLUTION 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-647 ACETAMINOPHEN INJECTION, SOLUTION [GLAND PHARMA LIMITED] 4 Current NDC, 2 package rows 20250406_db5d4cf8-762a-4111-971e-91c704bc3643.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 · 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 68083-647-01 68083064701 24 BAG in 1 CARTON (68083-647-01) / 50 mL in 1 BAG 24 bag 2025-04-02 No No Current