Prescription drug · NDA
Provera (Medroxyprogesterone acetate) NDC 0009-0065
Medroxyprogesterone acetate 2.5 mg/1 · Tablet · Oral · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-0065-01 | 0000900650100009006501 | 100 TABLET in 1 BOTTLE (0009-0065-01)Marketed from Sep 3, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Provera
- Generic name (nonproprietary)
- medroxyprogesterone acetate
- Active ingredients
- Medroxyprogesterone acetate — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Pharmacia & Upjohn Company LLCNDC labeler code 0009
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 011839
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0009-0065_ebcdf2fb-760c-4a9a-80a1-a0c6b21a891aSPL ID ebcdf2fb-760c-4a9a-80a1-a0c6b21a891aSPL set ID a586be28-96af-4fed-a13f-9b94fd4c7405RxCUI 1000114, 1000124, 1000135, 1000139, 1000141, 1000145UNII C2QI4IOI2G
- Pharmacologic class
- Progestin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400009006501followed by a unit qualifier and the quantityPackage 00009-0065-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE PROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
Excerpt only. Read the full label for complete information.
About NDC 0009-0065
- What is NDC 0009-0065?
- 0009-0065 is the product NDC for Provera (medroxyprogesterone acetate), Medroxyprogesterone acetate 2.5 mg/1 tablet, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Provera (Medroxyprogesterone acetate).
- What is the active ingredient?
- Medroxyprogesterone acetate.
- Who is the labeler?
- Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Provera?
- 2 other product NDCs are listed under this name. See all Provera NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Provera products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Proveramedroxyprogesterone acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Pharmacia & Upjohn Company LLC | 0009-0051 | 00009-0051-01 |
| Proveramedroxyprogesterone acetate | Medroxyprogesterone acetate 5 mg/1 | TabletOral | Pharmacia & Upjohn Company LLC | 0009-0287 | 00009-0287-01 |
Other NDCs under NDA 011839
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| medroxyprogesterone acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0055 |
| medroxyprogesterone acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0056 |
| medroxyprogesterone acetate | Medroxyprogesterone acetate 5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0058 |
| Proveramedroxyprogesterone acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Pharmacia & Upjohn Company LLC | 0009-0051 |
| Proveramedroxyprogesterone acetate | Medroxyprogesterone acetate 5 mg/1 | TabletOral | Pharmacia & Upjohn Company LLC | 0009-0287 |