Home NDC 0409-7811 Metronidazole
Product NDC 0409-7811
11-digit product format 004097811
Labeler code 0409
Product ID 0409-7811_4e9f4f41-dc89-45d4-bc9f-328c5ef7038d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METRONIDAZOLE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA018890
Marketing category NDA
Marketing start 2005-09-07
Marketing end 0000-00-00
Substance METRONIDAZOLE
Active strength 500 mg/100mL
Pharmacologic classes Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N018890-002 METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018890-002 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 2026-08-01 22:54:32 2026-06 N018890-002 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RLD, RS 1983-11-18 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N018890-002 AP 1 a50c72e98297…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 14 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 14 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 14 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 14 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 14 WATER INACTIVE INGREDIENT 059QF0KO0R METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 14 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 2 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 2 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R METRONIDAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-7811-24 00409781124 24 POUCH in 1 CASE (0409-7811-24) > 1 BAG in 1 POUCH > 100 mL in 1 BAG (0409-7811-31) 24 pouch 2005-09-07 0000-00-00 No No Current 0409-7811-37 00409781137 20 POUCH in 1 CASE (0409-7811-37) > 4 BAG in 1 POUCH (0409-7811-32) > 100 mL in 1 BAG (0409-7811-11) 20 pouch 2005-09-19 0000-00-00 No No Current