Oxytocin

Product NDC
0641-6114
11-digit product format
006416114
Labeler code
0641
Product ID
0641-6114_43bde17d-d249-4ad7-9136-a4ecd9dc648d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxytocin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA018243
Marketing category
NDA
Marketing start
1980-04-29
Marketing end
0000-00-00
Substance
OXYTOCIN
Active strength
10 [USP'U]/mL
Pharmacologic classes
Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0641-6114IInactivated by FDA2026-08-07
excluded packagepackage0641-61140641-6114-25IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0641-6114-25IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0641-6114-25IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0641-6114-25IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0641-6114-25IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0641-6114-25IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0641-6114-25IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0641-6114-25UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0641-6114-25UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0641-6114-25UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
N018243-001OXYTOCINOXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N018243-002OXYTOCINOXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018243-001AP
N018243-002AP

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018243-001OXYTOCIN10USP UNITS/ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N018243-002OXYTOCIN100USP UNITS/10ML (10USP UNITS/ML)INJECTABLE / INJECTIONAPRLD, RS2007-01-10782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018243-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018243-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018243-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018243-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018243-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018243-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018243-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018243-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018243-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018243-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018243-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018243-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018243-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018243-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018243-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018243-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018243-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018243-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018243-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018243-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018243-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018243-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018243-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018243-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018243-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018243-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018243-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018243-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018243-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018243-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018243-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018243-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018243-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018243-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018243-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018243-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018243-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018243-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018243-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N018243-002AP1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3124a9ec-4142-06dc-5b1b-5c28cd8ea2fbProduct name220180829
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6114-252025-01-30C16284748780-12cef2736-7f27-d83d-e063-dadaa90ab31fOxytocin Injection, USP (synthetic)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6114-01Oxytocin1 mL in 1 VIALINJECTION13
0641-6114-25Oxytocin25 in 1 CARTONINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6114-01ML - Milliliter0641-61147fdc1af7-bf9e-4009-95a0-9356cf6b072812012-07-24
0641-6114-25ML - Milliliter0641-6114160f0229-de08-4cd8-8be5-46166c0ded5612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYTOCINACTIVE INGREDIENT1JQS135EYNOXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
OXYTOCINACTIVE MOIETY1JQS135EYNOXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCOXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0ROXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6114OXYTOCIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]3Legacy NDC, 2 package rows20191231_a9b62187-4141-487c-a9da-f42ad7f9b408.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791721oxytocin 10 UNT in 1 ML InjectionPSNa9b62187-4141-487c-a9da-f42ad7f9b4083
238013oxytocin 10 UNT/ML Injectable SolutionPSNa9b62187-4141-487c-a9da-f42ad7f9b4083
17917211 ML oxytocin 10 UNT/ML InjectionSCDa9b62187-4141-487c-a9da-f42ad7f9b4083
238013oxytocin 10 UNT/ML Injectable SolutionSCDa9b62187-4141-487c-a9da-f42ad7f9b4083
1791721oxytocin 10 UNT per 1 ML InjectionSYa9b62187-4141-487c-a9da-f42ad7f9b4083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6114-01006416114011 mL in 1 VIAL1 mlHistorical
0641-6114-250064161142525 VIAL in 1 CARTON (0641-6114-25) > 1 mL in 1 VIAL (0641-6114-01) 25 vial1980-04-290000-00-00NoNoCurrent