Home NDC 0143-9150 COMBOGESIC IV
Product NDC 0143-9150
11-digit product format 001439150
Labeler code 0143
Product ID 0143-9150_8438b258-011d-4734-86f7-be0334c9db34
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acetaminophen and ibuprofen injection
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA215320
Marketing category NDA
Marketing start 2024-02-05
Substance ACETAMINOPHEN; IBUPROFEN
Active strength 1000; 300 mg/100mL; mg/100mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215320-001 COMBOGESIC IV ACETAMINOPHEN; IBUPROFEN SODIUM 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215320-001 11446266 2031-10-26 U-3744 2023-11-16 N215320-001 11446266 2031-10-26 U-3745 2023-11-16 N215320-001 11896567 2031-10-26 U-3744 2024-03-12 N215320-001 11896567 2031-10-26 U-3745 2024-03-12 N215320-001 12220392 2031-10-26 U-4306 2025-11-06 N215320-001 12220392 2031-10-26 U-4307 2025-11-06 N215320-001 11389416 2035-07-17 Drug product 2023-11-16 N215320-001 12083087 2035-07-17 U-3744 2024-10-08 N215320-001 12083087 2035-07-17 U-3745 2024-10-08 N215320-001 11213498 2036-01-14 Drug product 2023-11-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215320-001 NP 2026-10-17
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 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215320-001 COMBOGESIC IV 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-17 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 148 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215320-001 11446266 2031-10-26 U-3744 2023-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215320-001 11446266 2031-10-26 U-3745 2023-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215320-001 11896567 2031-10-26 U-3744 2024-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215320-001 11896567 2031-10-26 U-3745 2024-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215320-001 12220392 2031-10-26 U-4306 2025-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215320-001 12220392 2031-10-26 U-4307 2025-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215320-001 11389416 2035-07-17 Drug product 2023-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215320-001 12083087 2035-07-17 U-3744 2024-10-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215320-001 12083087 2035-07-17 U-3745 2024-10-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215320-001 11213498 2036-01-14 Drug product 2023-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215320-001 11446266 2031-10-26 U-3744 2023-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215320-001 11446266 2031-10-26 U-3745 2023-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215320-001 11896567 2031-10-26 U-3744 2024-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215320-001 11896567 2031-10-26 U-3745 2024-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215320-001 12220392 2031-10-26 U-4306 2025-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215320-001 12220392 2031-10-26 U-4307 2025-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215320-001 11389416 2035-07-17 Drug product 2023-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215320-001 12083087 2035-07-17 U-3744 2024-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215320-001 12083087 2035-07-17 U-3745 2024-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215320-001 11213498 2036-01-14 Drug product 2023-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215320-001 11446266 2031-10-26 U-3744 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215320-001 11446266 2031-10-26 U-3745 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215320-001 11896567 2031-10-26 U-3744 2024-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215320-001 11896567 2031-10-26 U-3745 2024-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215320-001 12220392 2031-10-26 U-4306 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215320-001 12220392 2031-10-26 U-4307 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215320-001 11389416 2035-07-17 Drug product 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215320-001 12083087 2035-07-17 U-3744 2024-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215320-001 12083087 2035-07-17 U-3745 2024-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215320-001 11213498 2036-01-14 Drug product 2023-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 11446266 2031-10-26 U-3744 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 11446266 2031-10-26 U-3745 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 11896567 2031-10-26 U-3744 2024-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 11896567 2031-10-26 U-3745 2024-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 12220392 2031-10-26 U-4306 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 12220392 2031-10-26 U-4307 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 11389416 2035-07-17 Drug product 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 12083087 2035-07-17 U-3744 2024-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 12083087 2035-07-17 U-3745 2024-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215320-001 11213498 2036-01-14 Drug product 2023-11-16 31067a03dcf5…
Observed Orange Book exclusivity 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 COMBOGESIC IV
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 1000 mg/100mL IBUPROFEN 300 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2673874 Internal RxNorm lookup 2673880 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 0143-9150-01 COMBOGESIC IV 100 mL in 1 VIAL INJECTION 100 5 0143-9150-10 COMBOGESIC IV 10 in 1 CARTON INJECTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9150 COMBOGESIC IV (ACETAMINOPHEN AND IBUPROFEN INJECTION) INJECTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, 2 package rows 20240508_be408a5a-48e4-43c0-9cb1-bbf830b54f5b.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 COMBOGESIC IV ACETAMINOPHEN AND IBUPROFEN INJECTION Hikma Pharmaceuticals USA Inc. be408a5a-48e4-43c0-9cb1-bbf830b54f5b 2024-11-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 215320 application number: NDA215320 ndc (product): 0143-9150
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0143-9150-01 00143915001 100 mL in 1 VIAL 100 ml Historical 0143-9150-10 00143915010 10 VIAL in 1 CARTON (0143-9150-10) / 100 mL in 1 VIAL (0143-9150-01) 10 vial 2024-02-05 No No Current