Home NDC 24201-010 Pentobarbital Sodium
Product NDC 24201-010
11-digit product format 242010010
Labeler code 24201
Product ID 24201-010_092d00fe-9f8a-47ea-b9bc-07ef41d2b418
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pentobarbital Sodium
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA203619
Marketing category ANDA
Marketing start 2025-10-01
Substance PENTOBARBITAL SODIUM
Active strength 50 mg/mL
DEA schedule CII
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 42 .
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 A203619-001 PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203619-001 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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203619-001 PENTOBARBITAL SODIUM 50MG/ML INJECTABLE / INJECTION AP 2017-11-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pentobarbital Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENTOBARBITAL SODIUM 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NJJ0475N0S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238090 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 24201-010-20 Pentobarbital Sodium 1 in 1 CARTON INJECTION, SOLUTION 1 5 24201-010-20 Pentobarbital Sodium 20 mL in 1 VIAL INJECTION, SOLUTION 20 5 24201-010-50 Pentobarbital Sodium 1 in 1 CARTON INJECTION, SOLUTION 1 5 24201-010-50 Pentobarbital Sodium 50 mL in 1 VIAL INJECTION, SOLUTION 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24201-010 PENTOBARBITAL SODIUM INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC. (DBA LEUCADIA PHARMACEUTICALS)] 4 Current NDC, Legacy NDC, 4 package rows 20230111_d375b92a-baa1-4d63-9ad1-1467dcfde7d5.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24201-010-20 24201001020 1 VIAL in 1 CARTON (24201-010-20) / 20 mL in 1 VIAL 1 vial 2025-10-01 0000-00-00 No No Current 24201-010-50 24201001050 1 VIAL in 1 CARTON (24201-010-50) / 50 mL in 1 VIAL 1 vial 2025-10-01 0000-00-00 No No Current