Home NDC 43066-121 Diazepam
Product NDC 43066-121
11-digit product format 430660121
Labeler code 43066
Product ID 43066-121_a0813073-d0b0-4fd7-b307-56f69c910c82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diazepam
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA219882
Marketing category ANDA
Marketing start 2026-07-28
Substance DIAZEPAM
Active strength 10 mg/2mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
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 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 A219882-001 DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2026-07-28 A219882-002 DIAZEPAM DIAZEPAM 20MG/4ML (5MG/ML) INJECTABLE / INJECTION RS 2026-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219882-001 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 2026-09-14 22:38:34 2026-08 A219882-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2026-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219882-002 DIAZEPAM 20MG/4ML (5MG/ML) INJECTABLE / INJECTION RS 2026-07-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219882-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2026-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219882-002 DIAZEPAM 20MG/4ML (5MG/ML) INJECTABLE / INJECTION RS 2026-07-28 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219882-001 AP 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219882-001 AP 1 caaa826d4ba7…
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 Diazepam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZEPAM 10 mg/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q3JTX2Q7TU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2120550 Internal RxNorm lookup 2749119 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 Diazepam DIAZEPAM Baxter Healthcare Corporation a0813073-d0b0-4fd7-b307-56f69c910c82 2026-05-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219882 application number: ANDA219882 ndc (product): 43066-121
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43066-121-10 43066012110 10 CARTON in 1 CARTON (43066-121-10) / 1 SYRINGE, PLASTIC in 1 CARTON (43066-121-01) / 2 mL in 1 SYRINGE, PLASTIC 10 carton 2026-07-28 No No Current