Home NDC 0781-3550 Heparin Sodium
Product NDC 0781-3550
11-digit product format 007813550
Labeler code 0781
Product ID 0781-3550_2ef18b0f-ccc2-5539-e063-6394a90a2a4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Heparin Sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Sandoz Inc.
Application ANDA202733
Marketing category ANDA
Marketing start 2014-06-12
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202733-001 HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202733-001 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 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202733-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2014-06-12 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 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 · 5 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 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 0781-3550-10 Heparin Sodium 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 4 0781-3550-25 Heparin Sodium 25 in 1 CARTON INJECTION, SOLUTION 25 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3550 HEPARIN SODIUM INJECTION, SOLUTION [SANDOZ INC.] 4 Current NDC, 2 package rows 20250226_1c634e53-44d6-cdcd-e063-6294a90a92e9.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 · 3 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 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1361226 heparin sodium, porcine 1000 UNT/ML Injectable Solution PSN 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1361574 heparin sodium, porcine 20,000 UNT/ML Injectable Solution PSN 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1658647 heparin sodium, porcine 2000 UNT in 2 ML Injection PSN 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1361615 heparin sodium, porcine 5000 UNT/ML Injectable Solution PSN 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1658647 2 ML heparin sodium, porcine 1000 UNT/ML Injection SCD 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1361226 heparin sodium, porcine 1000 UNT/ML Injectable Solution SCD 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1362831 heparin sodium, porcine 10000 UNT/ML Injectable Solution SCD 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1361574 heparin sodium, porcine 20000 UNT/ML Injectable Solution SCD 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1361615 heparin sodium, porcine 5000 UNT/ML Injectable Solution SCD 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1362831 heparin sodium, porcine 10,000 UNT/ML Injectable Solution SY 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1361574 heparin sodium, porcine 20,000 UNT/ML Injectable Solution SY 1c634e53-44d6-cdcd-e063-6294a90a92e9 4 1658647 heparin sodium, porcine 2000 UNT per 2 ML Injection SY 1c634e53-44d6-cdcd-e063-6294a90a92e9 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0781-3550-10 00781355010 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical 0781-3550-25 00781355025 25 VIAL, MULTI-DOSE in 1 CARTON (0781-3550-25) / 10 mL in 1 VIAL, MULTI-DOSE (0781-3550-10) 2024-09-16 No No Current