Vasopressin

Product NDC
25021-474
11-digit product format
250210474
Labeler code
25021
Product ID
25021-474_c264bd5a-2111-48fc-8c43-1bd12d44006b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vasopressin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA216963
Marketing category
ANDA
Marketing start
2024-11-15
Substance
VASOPRESSIN
Active strength
20 [USP'U]/mL
Pharmacologic classes
Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216963-001VASOPRESSINVASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-09
A216963-002VASOPRESSIN IN DEXTROSE 5%VASOPRESSIN40UNITS/100ML (0.4UNITS/ML)SOLUTION / INTRAVENOUSAP2025-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A216963-001AP
A216963-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216963-002VASOPRESSIN IN DEXTROSE 5%40UNITS/100ML (0.4UNITS/ML)SOLUTION / INTRAVENOUSAP2025-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216963-002VASOPRESSIN IN DEXTROSE 5%40UNITS/100ML (0.4UNITS/ML)SOLUTION / INTRAVENOUSAP2025-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-096a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216963-001VASOPRESSIN20UNITS/ML (20UNITS/ML)SOLUTION / INTRAVENOUSAP2024-02-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216963-002VASOPRESSIN IN DEXTROSE 5%40UNITS/100ML (0.4UNITS/ML)SOLUTION / INTRAVENOUSAP2025-08-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216963-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216963-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216963-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216963-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216963-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216963-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216963-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216963-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216963-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216963-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216963-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216963-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216963-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216963-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216963-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216963-001AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216963-001AP16a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216963-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216963-002AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Vasopressin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VASOPRESSIN20 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Y4907O6MFDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2103182Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ad3ac280-49da-4816-9097-14517d0c0f85Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99568ea8-9af8-47ab-8eb5-5730f9428dbdProduct name120250625
0f6574b6-8c6c-4325-9a2b-e8f85e32ee4eProduct name120250305
704c08d7-cc3f-4fb2-a29e-57130a255781Product name420241218
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
6ac8356f-c51e-45ae-a595-aa1fad5b69a2Product name120210223
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-474-01Vasopressin25 in 1 CARTONINJECTION, SOLUTION251
25021-474-01Vasopressin1 mL in 1 VIALINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-474-01ML - Milliliter25021-4749b515563-5e77-4a9e-af6f-6d8b0098a99512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-474VASOPRESSIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20241119_ad3ac280-49da-4816-9097-14517d0c0f85.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VasopressinVASOPRESSINGland Pharma Limited971f9b1c-6094-4f80-920b-cb5d7e62950a2025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216963
application number: ANDA216963
VasopressinVASOPRESSINSagent Pharmaceuticalsad3ac280-49da-4816-9097-14517d0c0f852024-11-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216963
application number: ANDA216963
ndc (product): 25021-474

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2103182vasopressin 20 UNT in 1 mL InjectionPSNad3ac280-49da-4816-9097-14517d0c0f851
21031821 ML vasopressin (USP) 20 UNT/ML InjectionSCDad3ac280-49da-4816-9097-14517d0c0f851
2103182vasopressin 20 UNT per 1 ML InjectionSYad3ac280-49da-4816-9097-14517d0c0f851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-474-012502104740125 VIAL in 1 CARTON (25021-474-01) / 1 mL in 1 VIAL25 vial2024-11-15NoNoCurrent