Home NDC 63323-047 Heparin Sodium
Product NDC 63323-047
11-digit product format 633230047
Labeler code 63323
Product ID 63323-047_529104c9-6154-4428-953d-5546875f32e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HEPARIN SODIUM
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application NDA017651
Marketing category NDA
Marketing start 1978-02-10
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 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017651-003 HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 N017651-005 HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 N017651-006 HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 N017651-008 HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N017651-006 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 5 · 164 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 2026-02-19 14:30 UTC 2026-02 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Heparin Sodium
Listing expiration 2026-12-31 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361226 Internal RxNorm lookup 1361574 Internal RxNorm lookup 1361615 Internal RxNorm lookup 1362831 Internal RxNorm lookup 1658634 Internal RxNorm lookup 1658647 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 63323-047-01 Heparin Sodium 10 mL in 1 VIAL INJECTION, SOLUTION 10 13 63323-047-10 Heparin Sodium 25 in 1 TRAY INJECTION, SOLUTION 25 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HEPARIN SODIUM ACTIVE INGREDIENT ZZ45AB24CA HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 9 HEPARIN ACTIVE MOIETY T2410KM04A HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 9 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 9 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 9 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 9 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 9 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-047 HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 12 Current NDC, Legacy NDC, 2 package rows 20241017_d55b4a63-0c04-4874-b74f-9e9b9e8b008c.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# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1362831 heparin sodium, porcine 10,000 UNT/ML Injectable Solution PSN d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1361226 heparin sodium, porcine 1000 UNT/ML Injectable Solution PSN d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1361574 heparin sodium, porcine 20,000 UNT/ML Injectable Solution PSN d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1658647 heparin sodium, porcine 2000 UNT in 2 ML Injection PSN d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1658634 heparin sodium, porcine 5000 UNT in 0.5 mL Injection PSN d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1361615 heparin sodium, porcine 5000 UNT/ML Injectable Solution PSN d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1658634 0.5 ML heparin sodium, porcine 10000 UNT/ML Injection SCD d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1658647 2 ML heparin sodium, porcine 1000 UNT/ML Injection SCD d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1361226 heparin sodium, porcine 1000 UNT/ML Injectable Solution SCD d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1362831 heparin sodium, porcine 10000 UNT/ML Injectable Solution SCD d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1361574 heparin sodium, porcine 20000 UNT/ML Injectable Solution SCD d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1361615 heparin sodium, porcine 5000 UNT/ML Injectable Solution SCD d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1362831 heparin sodium, porcine 10,000 UNT/ML Injectable Solution SY d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1361574 heparin sodium, porcine 20,000 UNT/ML Injectable Solution SY d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1658647 heparin sodium, porcine 2000 UNT per 2 ML Injection SY d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13 1658634 heparin sodium, porcine 5000 UNT per 0.5 ML Injection SY d55b4a63-0c04-4874-b74f-9e9b9e8b008c 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-047-01 63323004701 10 mL in 1 VIAL 10 ml Historical 63323-047-10 63323004710 25 VIAL in 1 TRAY (63323-047-10) > 10 mL in 1 VIAL (63323-047-01) 25 vial 2000-03-19 0000-00-00 No No Current