Home NDC 55154-2827 Heparin Sodium
Product NDC 55154-2827
11-digit product format 551542827
Labeler code 55154
Product ID 55154-2827_8ff13251-1ffd-4a33-8037-7dc7bfc1f2a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Heparin Sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Cardinal Health 107, LLC
Application ANDA090808
Marketing category ANDA
Marketing start 2010-07-06
Substance HEPARIN SODIUM
Active strength 5000 [USP'U]/mL
Pharmacologic classes Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090808-001 HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 A090808-002 HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 A090808-003 HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
Product history page 1 of 4 · 126 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 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090808-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090808-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090808-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2010-06-30 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Heparin Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HEPARIN SODIUM 5000 [USP'U]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZZ45AB24CA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361615 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 55154-2827-5 Heparin Sodium 5 in 1 BAG INJECTION, SOLUTION 5 19 55154-2827-5 Heparin Sodium 1 mL in 1 VIAL INJECTION, SOLUTION 1 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-2827 HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] 19 Current NDC, Legacy NDC, 2 package rows 20250507_e0cc5f44-9a67-4274-a48a-d6118e96d391.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 · 5 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 55154-2827-5 55154282705 5 VIAL in 1 BAG (55154-2827-5) / 1 mL in 1 VIAL 5 vial 2010-07-06 0000-00-00 No No Current