Home NDC 0069-0043-01 Heparin Sodium
Product NDC 0069-0043
Requested package NDC 0069-0043-01
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.
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 2026-08-01 22:54:32 2026-06 N201370-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N201370-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N201370-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION RLD 2011-07-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N201370-004 HEPARIN SODIUM PRESERVATIVE FREE 1,000 UNITS/ML INJECTABLE / INJECTION RLD, RS 2011-07-21 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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