Progesterone

Product NDC
70700-162
11-digit product format
707000162
Labeler code
70700
Product ID
70700-162_181873be-16cc-352d-9568-03af070a1fc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
CAPSULE
Route
ORAL
Labeler
Xiromed, LLC
Application
ANDA205229
Marketing category
ANDA
Marketing start
2021-01-08
Substance
PROGESTERONE
Active strength
100 mg/1
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A205229-001PROGESTERONEPROGESTERONE100MGCAPSULE / ORALAB2017-10-20
A205229-002PROGESTERONEPROGESTERONE200MGCAPSULE / ORALAB2017-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205229-001AB
A205229-002AB

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 UTC2026-02A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205229-001PROGESTERONE100MGCAPSULE / ORALAB2017-10-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A205229-002PROGESTERONE200MGCAPSULE / ORALAB2017-10-20782e0a99824c…

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 UTC2026-02A205229-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205229-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205229-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205229-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205229-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205229-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205229-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205229-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205229-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205229-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205229-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205229-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205229-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205229-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205229-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205229-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205229-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205229-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205229-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205229-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205229-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205229-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205229-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205229-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205229-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205229-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205229-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205229-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205229-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205229-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205229-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205229-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205229-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205229-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205229-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205229-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205229-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205229-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205229-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205229-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Progesterone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4G7DS2Q64YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
260243Internal RxNorm lookup
312641Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0bf317a8-96d6-849d-7850-9084205a5315Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-162-01Progesterone100 in 1 BOTTLECAPSULE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-162-01EA - Each70700-162aebfbd09-925c-40f1-bcfd-6f9e1aee855a12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-162PROGESTERONE CAPSULE [XIROMED, LLC]4Current NDC, Legacy NDC, 1 package rows20240517_0bf317a8-96d6-849d-7850-9084205a5315.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProgesteronePROGESTERONERedpharm Drug5743b2e4-093f-c59a-e063-6394a90aae2b2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEBryant Ranch Prepack1ba10f9d-6e91-4954-ac91-23adcf8805b02026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEBryant Ranch Prepack74a7619a-8f74-4889-96f6-5bae478543e82026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEAvKARE1637ac18-3a37-f3d5-e063-6394a90af1572026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONENorthstar Rx LLC73229a76-8de3-4cea-886f-568f0b817fea2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEXiromed, LLC0bf317a8-96d6-849d-7850-9084205a53152026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ndc (product): 70700-162
ProgesteronePROGESTERONEDirect_Rx462ae686-7264-4852-e063-6294a90aae982025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEPreferred Pharmaceuticals Inc.67842863-209d-4724-9e67-8d0c6282bd1d2025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
PROGESTERONEPROGESTERONEDirect Rxdc9e2088-e11e-7d32-e053-2a95a90a29952025-01-22WarningsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEProficient Rx LP80a63b2b-96be-423d-abbd-13acc802f6da2024-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEA-S Medication Solutions96c59a1c-d562-46dd-868b-b2decdfef3192023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEAsclemed USA, Inc.fd6b9861-04fc-42d8-90c8-021a69fe93e92023-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEA-S Medication Solutions5e0263c5-2cb6-4e02-b883-2c05492a62602023-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEAsclemed USA, Inc.4a741977-1dbb-41e7-a560-9ac02936f8b12022-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEProficient Rx LPe1546b35-cfa8-4808-9652-db1ba675a4e32022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229
ProgesteronePROGESTERONEProficient Rx LP73e65b35-2266-48a3-98f8-521446a55c222022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205229
application number: ANDA205229

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN1ba10f9d-6e91-4954-ac91-23adcf8805b0103
260243progesterone 100 MG Oral CapsuleSCD1ba10f9d-6e91-4954-ac91-23adcf8805b0103
260243progesterone 100 MG Oral CapsulePSN0bf317a8-96d6-849d-7850-9084205a53159
312641progesterone 200 MG Oral CapsulePSN0bf317a8-96d6-849d-7850-9084205a53159
260243progesterone 100 MG Oral CapsuleSCD0bf317a8-96d6-849d-7850-9084205a53159
312641progesterone 200 MG Oral CapsuleSCD0bf317a8-96d6-849d-7850-9084205a53159
260243progesterone 100 MG Oral CapsulePSN67842863-209d-4724-9e67-8d0c6282bd1d4
312641progesterone 200 MG Oral CapsulePSN67842863-209d-4724-9e67-8d0c6282bd1d4
260243progesterone 100 MG Oral CapsuleSCD67842863-209d-4724-9e67-8d0c6282bd1d4
312641progesterone 200 MG Oral CapsuleSCD67842863-209d-4724-9e67-8d0c6282bd1d4
260243progesterone 100 MG Oral CapsulePSNee281648-7d7d-418a-e053-2995a90af59b2
260243progesterone 100 MG Oral CapsulePSN73e65b35-2266-48a3-98f8-521446a55c222
312641progesterone 200 MG Oral CapsulePSN73e65b35-2266-48a3-98f8-521446a55c222
260243progesterone 100 MG Oral CapsuleSCD73e65b35-2266-48a3-98f8-521446a55c222
260243progesterone 100 MG Oral CapsuleSCDee281648-7d7d-418a-e053-2995a90af59b2
312641progesterone 200 MG Oral CapsuleSCD73e65b35-2266-48a3-98f8-521446a55c222
260243progesterone 100 MG Oral CapsulePSN462ae686-7264-4852-e063-6294a90aae981
260243progesterone 100 MG Oral CapsulePSN5e0263c5-2cb6-4e02-b883-2c05492a62601
260243progesterone 100 MG Oral CapsulePSNcf43bebf-1c69-aa76-e053-2995a90a6ccc1
260243progesterone 100 MG Oral CapsulePSNe1546b35-cfa8-4808-9652-db1ba675a4e31
260243progesterone 100 MG Oral CapsulePSN4a741977-1dbb-41e7-a560-9ac02936f8b11
312641progesterone 200 MG Oral CapsulePSN4a741977-1dbb-41e7-a560-9ac02936f8b11
260243progesterone 100 MG Oral CapsuleSCD462ae686-7264-4852-e063-6294a90aae981
260243progesterone 100 MG Oral CapsuleSCD4a741977-1dbb-41e7-a560-9ac02936f8b11
260243progesterone 100 MG Oral CapsuleSCDcf43bebf-1c69-aa76-e053-2995a90a6ccc1
260243progesterone 100 MG Oral CapsuleSCDe1546b35-cfa8-4808-9652-db1ba675a4e31
260243progesterone 100 MG Oral CapsuleSCD5e0263c5-2cb6-4e02-b883-2c05492a62601
312641progesterone 200 MG Oral CapsuleSCD4a741977-1dbb-41e7-a560-9ac02936f8b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-162-0170700016201100 CAPSULE in 1 BOTTLE (70700-162-01) 100 capsule2021-01-080000-00-00NoNoCurrent