Home NDC 0069-0043 Heparin Sodium
Product NDC 0069-0043
11-digit product format 000690043
Labeler code 0069
Product ID 0069-0043_4ba8e8f9-4192-46ea-96b0-6a2e45547581
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Heparin Sodium
Dosage form INJECTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA201370
Marketing category NDA
Marketing start 2011-07-21
Substance HEPARIN SODIUM
Active strength 1000 [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 N201370-001 HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 N201370-002 HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 N201370-003 HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21
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 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 d06236e962d9…
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 1000 [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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361226 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 0069-0043-01 Heparin Sodium 25 in 1 CONTAINER INJECTION 25 32 0069-0043-02 Heparin Sodium 2 mL in 1 VIAL INJECTION 2 32
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0043 HEPARIN SODIUM INJECTION [PFIZER LABORATORIES DIV PFIZER INC] 29 Current NDC, Legacy NDC, 2 package rows 20241004_56dc3074-f1c5-45a3-b923-f1d14858e06d.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 56dc3074-f1c5-45a3-b923-f1d14858e06d 32 1361226 heparin sodium, porcine 1000 UNT/ML Injectable Solution PSN 56dc3074-f1c5-45a3-b923-f1d14858e06d 32 1658647 heparin sodium, porcine 2000 UNT in 2 ML Injection PSN 56dc3074-f1c5-45a3-b923-f1d14858e06d 32 1361615 heparin sodium, porcine 5000 UNT/ML Injectable Solution PSN 56dc3074-f1c5-45a3-b923-f1d14858e06d 32 1658647 2 ML heparin sodium, porcine 1000 UNT/ML Injection SCD 56dc3074-f1c5-45a3-b923-f1d14858e06d 32 1361226 heparin sodium, porcine 1000 UNT/ML Injectable Solution SCD 56dc3074-f1c5-45a3-b923-f1d14858e06d 32 1362831 heparin sodium, porcine 10000 UNT/ML Injectable Solution SCD 56dc3074-f1c5-45a3-b923-f1d14858e06d 32 1361615 heparin sodium, porcine 5000 UNT/ML Injectable Solution SCD 56dc3074-f1c5-45a3-b923-f1d14858e06d 32 1362831 heparin sodium, porcine 10,000 UNT/ML Injectable Solution SY 56dc3074-f1c5-45a3-b923-f1d14858e06d 32 1658647 heparin sodium, porcine 2000 UNT per 2 ML Injection SY 56dc3074-f1c5-45a3-b923-f1d14858e06d 32
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0069-0043-01 00069004301 25 VIAL in 1 CONTAINER (0069-0043-01) / 2 mL in 1 VIAL (0069-0043-02) 25 vial 2011-07-21 0000-00-00 No No Current 0069-0043-02 00069004302 2 mL in 1 VIAL 2 ml Historical